US20080140250A1

US20080140250A1 - Secure Dispensing System

Info

Publication number: US20080140250A1
Application number: US11/660,030
Authority: US
Inventors: Rajiv Bobby Dave
Original assignee: GW Pharmaceuticals PLC
Current assignee: GW Pharmaceuticals PLC
Priority date: 2004-08-10
Filing date: 2005-08-09
Publication date: 2008-06-12
Also published as: GB2417116A; WO2006016150A1; EP1776670A1; CA2576126A1; GB0417793D0; AU2005271060A1

Abstract

A secure dispensing system comprising a container (10) arranged to dispense a quantity of a material through a delivery port (40). The system has a locking mechanism to prevent the dispensing of the material and a control device (70) to enable release of the locking mechanism. A key (110) is also provided to allow access to restricted functions of the system. The system will only enable release of the locking mechanism once a user has been authenticated by one or more biometric means of identification. The key (110) may also comprises a biometric means of authentication which must be provided in order to functionalize the key (110).

Description

The present invention relates to a secure dispensing system, comprising a container with a locking mechanism, which prevents the dispensing of material from the container until the locking mechanism is released. The secure dispensing system also comprises a control device, which is arranged to enable the release of the locking mechanism thereby allowing material to be dispensed from the container. Preferably a key is also provided to enable access to restricted functions of the system. The system will only enable release of the locking mechanism when a user has been authenticated by one or more biometric means of identification. More preferably, but not exclusively, the secure dispensing system comprises RFID tags as a means to communicate with various parts of the system. More preferably, but not exclusively, the secure dispensing system is used to dispense a pharmaceutical product. Preferably the secure dispensing system is able to trace the movement of material along different parts of a supply chain.

BACKGROUND TO THE INVENTION

The movement of goods from one destination to another or even simply the dispensing of these goods from a container may require more security than can be achieved by a simple lock and key assembly alone.
For example, pharmaceutical products are often valuable assets and as such it is important to ensure that once these goods leave their point of manufacture they are not diverted or lost in the supply chain.
It is extremely difficult to keep track of pharmaceutical goods due to the fact that they are often manufactured at a site and then transported via several warehouses before finally arriving at their destination pharmacy. This transit period may take several days or weeks and the increased transit time and the number of different shipment holds that the goods arrive at and are transported out of, can proliferate the chances of the goods being diverted or lost.
In the case of pharmaceutical products which are controlled drugs or drugs of abuse the requirement for the goods to be secure at all times during their shipment and dispensing is of utmost importance.
Once a pharmacist has dispensed a pharmaceutical product for example, a prescribed drug, to a patient all control over the drugs use and how it is taken is removed. This can cause many problems. In particular lack of control over pharmaceutical products, which are drugs of abuse can lead to serious problems if not dealt with.
Drugs of abuse are often opioid drugs (a term which includes not only drugs related chemically to morphine but also non-related structures which act at the same receptors in the brain). These include many of the controlled drugs listed in the 1971 Misuse of Drugs Act and other drugs, including fentanyl. Opioids are used primarily to alleviate pain, although some of the CNS mechanisms that reduce the perception of pain also produce euphoria, and as such opioid drugs may be taken for non-medicinal purposes in order to obtain the euphoric effect on mood. This gives the potential for abuse.
Dependence on opioid drugs arises from repeated administration of opioids and is characterised by an overwhelming need to continue taking the drug or one with similar properties. Users develop a tendency to increase the dose owing to development of tolerance, and may develop a psychological and physical dependence on the drug. Cross-tolerance and cross-dependence exists between opioids acting at the same receptors. Opioid analgesics, particularly diamorphine, are abused for their euphoric effects and dependence develops rapidly with regular use.
Methadone is a synthetic opioid, which is used as an analgesic and cough suppressant and as an alternative to diamorphine for treating opioid addicts. It is well absorbed orally, and when given to patients who are addicted to other opioids produces less acute oscillations between the high and early withdrawal symptoms. Withdrawal may develop more slowly with methadone than diamorphine.
Opioids themselves, such as methadone, are often used in the management of other opioid, particularly heroin, dependency. The usual method in the UK is to replace the diamorphine with methadone, which is given as a liquid oral preparation; this is then gradually withdrawn over a period of time. In other countries, other opioids such as buprenorphine may be used in for example, sublingual tablets or nasal spray form. Methadone is useful for withdrawal therapy because it can be given orally and its long half-life allows once-daily administration. Liquid oral preparations are usually preferred, and in withdrawal programmes it is usual for patients to attend pharmacies, or other treatment centres where the prescribed dose is given under supervision.
The average dose of methadone is between 60 and 120 mg per day. Methadone is available to pharmacies and clinics in a variety of forms such as; 1 mg/ml solution (500 ml bottle), 10 mg/ml solution in a 150 ml or a 500 ml bottle, 325 g bulk powder for preparation or ampoules at various concentrations.
The Drug Tariff Formula (DTF) of methadone is a solution of methadone hydrochloride in an aqueous solution of hydrogenated glucose syrup (Maltitol). It has a bitter taste, and this determines the volume and concentration that can be given at one time.
A patients access to managed doses of controlled drugs or drugs of abuse such as, for example, diamorphine and methadone, often must be under close professional supervision.
Although supervised administration of defined doses of an opioid is a recognised strategy for the treatment of diamorphine addicts, it requires the input of healthcare professionals, time and counseling to be effective.
Ideally, formulations in treatment regimens need to be presented in convenient formats, preferably with facilities available for recording dates and/or times of usage so as to control dosages administered remotely, i.e. without requiring the supervision of healthcare professionals at the time of administration.
At the present time there is no safe and secure means for administration of controlled drugs without close supervision of a healthcare professional. The high cost of supervision means that resources to treat patients may be limited. In the absence of close professional supervision the controlled drug or drug of abuse could be diverted to the black market or an overdose of the drug could be taken by the patient.
The present invention addresses the scenario where it is desirable to dispense pharmaceutical goods to a user via a secure dispensing system. The present invention describes a secure dispensing system and its component parts where a user is authenticated by a biometric means of identification.
A preferred embodiment of the various aspects of the invention comprises the incorporation of a control device, which is able to provide control over dispensing of the material within the container. Suitable technology for this level of control includes those described in GB2368061 and GB2368098, further improvements of which are described in GB2384707. Such systems generally comprise a dispenser, a locking mechanism on the dispenser to prevent dispensing of the material, a user interface allowing the user to input data, and a control device being arranged to receive the input data and to enable release of the locking mechanism to allow dispensing of the material.
The present invention obtains a further level of security over the dispensing systems described in the above applications as it requires a user to authenticate themselves to the system by a biometric means of identification. The use of a biometric means of identification overcomes the problems associated with simpler identification means such as Personal Identification Numbers (PIN) where a number can be easily diverted to an unauthorised user.
Another advantage that the present invention demonstrates is that once the pharmaceutical product is secured within the container it cannot be diverted for illicit sale or use. Another advantage is that a patient could not take more than their recommended daily dose.
When a drug of abuse such as methadone is supplied to a patient to take home there is a danger of a patient overdosing from their medication or a child could mistakenly take the medication and suffer from an overdose as a consequence to this.
Another clear advantage of the use of a secure dispensing system for supplying a drug such as methadone is the reduction in costs that would occur as a result. After the small initial outlay for the secure container and the control device, (both of which are reprogrammable and reusable), the costs of supplying methadone to treat an opiate addict are negligible. At present the cost of supervised consumption amounts to more than £20 per week per patient and with an estimated 10,000 to 15,000 patients currently undergoing supervised consumption of methadone in the UK, this amounts to a considerable cost.
In recent times there has been an increased need to supervise not only the patient but also the prescribing doctor and supplying pharmacist.
The use of this safer method of prescribing and supplying pharmaceutical products means that there is a secure audit trail, which can be checked at each level. This would mean that there was far less chance that doctors or pharmacists could misuse their position of authority to prescribe pharmaceutical goods.

SUMMARY OF INVENTION

According to a first aspect of the present invention, there is provided a secure dispensing system comprising the following:

- a container arranged to securely contain a quantity of a material within it comprising:
  - an internal locking mechanism to prevent unauthorised dispensing of the material from the container; and
  - a delivery port to enable dispensing of a quantity of the material from the container,
- a control device arranged to enable release of the internal locking mechanism to allow dispensing of the material once authorization of a user has taken place; and
- a key to enable a user to access restricted functions of the system,
- whereby the operation of the system is controlled by:
- authentication of a first user to the key to enable the user to access restricted functions of the system; and
- authentication of a second user to the control device to enable dispensing of the material from the container;
  whereby the authentication means of the user is by measurement of one or more biometric characteristics of the user.

The biometric means of identification of a user can be selected from any known biometric identification means. These include but are not limited to hand geometry, retina scan, iris scan, fingerprint, facial characteristics, DNA sequence characteristics or voiceprints.
Preferably the biometric means of authentication is one or more of the users fingerprints. The secure dispensing system may comprise means to scan and record one or more of a users fingerprints. In order to authenticate a user to the system, the system requests that the user swipes one or more of his fingerprints. If the fingerprint that has been swiped by the user matches the fingerprint that is stored by the system then the user is authenticated and can go on to access particular functions defined by the system. If the fingerprint does not match the fingerprint that is stored by the system then the user is not authenticated and is asked to retry. If the user fails to provide an authenticated fingerprint scan within a predetermined time period or number of attempts, the system may block the user until such a time that an authorised person unblocks the system.
Once a user is authenticated to the system he is able to access particular functions defined by the system. These functions may include, but are not limited to, the user being given access to dispense a dose of medicament. Once the authentication process is complete a timer starts whereby, for example, a dose can only be dispensed during a given time span. This can be as short as several seconds or longer depending on the requirements of the system and the user.
In order to ensure that the dispensing system is as secure as possible the container that contains the material that is to be dispensed is preferably manufactured from a material that is resistant to tamper. This means that the container is constructed from a material that can resist attack from tools that are typically available from hardware stores. The tools which are of particular interest, but are not limited to, are electric power drills with hammer action, circular saws, Jig Saws, Grinders with stone or metal discs, vice with 1 ton compression pressure and a 21b club hammer dropped repeatedly on to the container. By resistant to attack it is meant that the container is able to withstand interference from a tool or device for a period of time that is relevant to the type of tool. For example the use of a Jig Saw for over 30 minutes would render the Jig Saw blade blunt and useless and would also probably overheat the device. The container is preferably able to withstand tamper in this way.
In addition to the container being able to withstand attack from a tool the container is also preferably bullet-proof.
Preferably to ensure that the container is tamper and bullet-proof the material that the container is manufactured from is a composite material.
The composite material may comprise, but is not limited to, the following materials; aluminium, epoxy resin and silicon carbide. Other types of fibres or materials can be used to produce a composite material for use in the manufacture of the container. These include but are not limited to glass, wood, metals, concrete, silicon carbide, ceramic and titanium. The material can be woven or layered to produce a matrix.
The secure dispensing system further comprises a valve and pump assembly, which is preferably inaccessible to the system user. By inaccessible to the user it is meant that the valve and pump assembly is concealed within the locked container or other inaccessible area of the system.
In addition the valve and pump assembly is preferably disposable. By making the valve and pump assembly disposable it ensures that if the material that is to be dispensed is a poison or toxin or if the material that is to be replaced in the container is different from the material that is already in the container the valve and pump assembly will not contaminate the new material.
Preferably the valve and pump assembly is also arranged in the container to produce an indirect pathway to the delivery port. In this way the best possible security is maintained as a user is unable to remove the contents of the container by siphoning, suction or any other direct or indirect means.
The container has a delivery port from which the material held within the container is delivered through. Preferably the delivery port has a valve to prevent material from being extracted from the system's delivery port.
Preferably the container is a sealed unit with an internal locking mechanism that can be opened by an authorised person to allow the contents of the container to be replaced. In this way the container can be cost-effective, because the container is durable a user may only ever need to be allocated with one container. An authorised person can carry out the replacement of the material inside the container.
The container may also be equipped with a biometric authentication device. This is preferably a fingerprint scanner. The container can also be equipped with a tamper indicator, which would alert the user or another person if the device had been opened or accessed in an unauthorised manner.
Another part of the secure dispensing system is the control device. Preferably, but not essentially, the control device is detachable from the container. This enables the control device to be used on more than one container if necessary.
The control device may comprise a means for storing and transmitting data. This enables the control device to collect information such as a users biometric identification, information regarding the material that is to be dispensed, a dispensing regime or information about how the system is being used. This information can either be stored and subsequently downloaded when required or it can be transmitted to an authorised location or person. More preferably the means for storing and transmitting data is by one or more radio frequency identification (RFID) tags.
The control device preferably further comprises some or all of following features. A display screen, which can be used to facilitate communication with a user or other means of communication. A means for allowing data input, these could be simple buttons or more sophisticated means of communication such as a voice or sound recognition. The control device can also be equipped with a tamper indicator, which would alert the user or another person if the device had been opened or accessed in an unauthorised manner.
The control device can preferably communicate information to the user, this can be achieved by one of the means discussed above, although not limited to these means.
The control device may also be equipped with a biometric authentication device. This is preferably a fingerprint scanner.
According to a second aspect of the present invention, there is provided a key. The user of the key must firstly be authenticated in order to functionalize the key. Once authenticated to the key the user is permitted to access restricted functions relating to the system.
Preferably the means of authentication of a user is a biometric means. More preferably the biometric means of authentication is one or more of the users fingerprints. The key may comprise means to scan and record one or more of a users fingerprint. In order to authenticate a user, the key requests that the user swipes one or more of their fingerprints. If the fingerprint that has been swiped by the user matches the fingerprint that is stored by the key the user is then authenticated, this enables the user to access specific functions of the secure dispensing system. If the fingerprint does not match the fingerprint that is stored by the key then the user is not authenticated and is asked to retry. If a user makes more unsuccessful attempts to authenticate themselves they may be blocked from using the key.
Preferably the key has means for storing and transmitting data. More preferably this means for storing and transmitting data is one or more radio frequency identification (RFID) tags.
According to a third aspect of the present invention, there is provided a secure dispensing system whereby the different parts of the system are able to communicate with each other. Preferably this means of communication is achieved by one or more radio frequency identification (RFID) tags or other similar means of storing, transmitting and/or retrieving data.
Preferably there is provided a plurality of RFID tags, which are able to communicate with one another in order to authenticate the various components of the system.
Preferably an RFID tag associated with the material contained within the container communicates with an RFID tag reader associated with the container, which in turn communicates with an RFID tag reader associated with the control device, and wherein the dispensing of the material will only occur if the data that is communicated between the parts of the system is authorized by the system.
For example an RFID tag, which is associated with the contents of the container communicates with an RFID tag reader associated with the container this means that only material that is authorised to be dispensed from the container can be used. This method is of an advantage to ensure overall security of the system. For example if a bottle of medicament was placed inside the container and the type of medicament was not of the type required to be dispensed to a patient, an RFID tag associated with the label on the medicament bottle would be read by an RFID tag reader associated with the container and this RFID tag would in turn communicate this information to an RFID tag associated with the control device, thereby only allowing dispensing of the material if authenticated.
According to a fourth aspect of the present invention, the material that is dispensed from the secure dispensing system is a pharmaceutical product. Preferably but not essentially the material to be dispensed is a controlled drug or a drug of abuse.
Preferably the controlled drug or drug of abuse is a Class A drug as defined by The Misuse of Drugs Act 1971. More preferably the controlled drug or drug of abuse is an opioid. More preferably still the opioid is methadone or a pharmaceutically acceptable salt or derivative thereof. Even more preferably the opioid is methadone hydrochloride.
Preferably the secure dispensing system is able to dispense a measured dose of material contained within it according to a pre-programmed regime. More preferably the measured dose of material can be delivered in increments.

1. According to a fifth aspect of the present invention there is provided a method of securely dispensing a material from a container, said method comprising the steps of;
- Authentication of a first user to a key by one or more biometric means of identification;
- Communication of the data produced by authentication to a means for analysing the data;
- Analysis of the communicated data to determine whether the first user is permitted to access restricted functions of the system;
- Access to restricted functions of the system if the first user is authorised;
- Authentication of a second user to a control device by one or more biometric means of identification;
- Communication of the data produced by authentication to a means for analysing the data;
- Analysis of the communicated data to determine whether dispensing of the material from the container is permitted; and

Secure dispensing of material from the container if the second user is authorised.

Preferably the biometric means of authentication is a scan of one or more of the users fingerprints.
Preferably once the key is authenticated it allows the first user to open the container to enable the contents of container to be replaced or filled.
In addition, once authenticated to the key the user preferably has access to programme the control device to enable dispensing of material according to a regime.
Preferably, the communication of data between the control device and the container is achieved by RFID tags.
Preferably the material to be dispensed is a pharmaceutical product.

Certain aspects of this invention may be understood by way of example with reference to the accompanying drawings in which:

FIG. 1 details the management of material along parts of a supply chain; and

FIG. 2 details the secure dispensing system of the invention.

SPECIFIC DESCRIPTION

One particularly preferred such device for dispensing a pharmaceutical product will now be described, although it will of course be apparent that the invention may be effected with alternative materials for dispensation.
Referring to the drawings, by way of example FIG. 1 details the management of material along parts of a supply chain. The flow chart demonstrates the current way in which products such as pharmaceuticals are moved along a supply chain and the amount of control that is held over the pharmaceutical product at each point. At the first stage where the pharmaceutical product is manufactured complete control over the product is retained. But as the pharmaceutical product is moved from this site to wholesale distributors, then to the pharmacies, hospitals and clinics and finally on to the patient, control over the product is lost completely.
The callouts on the flow diagram detail the way in which the present invention aims to retain control over each step of the distribution chain. The use of a means for storing, receiving and/or transmitting data such as, for example, a Radio Frequency Identification (RFID) tag in this way ensures that the whereabouts of the material is known at all times.
For example an RFID tag can be programmed at the point of a products manufacture to contain information such as the name of the product, type or class of product, manufacturing date, expiry date, batch number etc. and this RFID tag can be applied to the product itself or to a label associated with the product. The product is then packaged for shipping where another RFID tag which has been programmed to contain information such as the number of batches in the carton, supplier's details, shipment details etc. may be applied. Upon exiting the warehouse an RFID tag reader may be used to record and log the details of the shipment. When the goods arrive at their destination and are logged in by an RFID tag reader a communication can be sent to acknowledge that the goods have arrived in a timely fashion at their destination. If they do not arrive an alert can be sent by the RFID tags associated with the goods to warn that the goods are not at their destination.
When the point of destination is a pharmacy the goods can be automatically logged into an electronic register, which can then automatically update if necessary once the pharmacy dispenses the goods.
By retaining control over all of these steps in the supply chain in this manner it is clear that there is virtually no means of unauthorised diversion of the goods. When the goods are of such a nature that they are valuable or addictive substances this is of clear importance.
FIG. 2 details the container from the secure dispensing system in both front and side elevation views. The container (10) is made from a composite material and a dose delivery port (20). A dose may be delivered directly to a drinking vessel for ease of dispensation to a user.
The container is produced in two parts, which are locked together by an internal locking mechanism, which is inaccessible to the user. This enables the contents of the container to be refilled or replaced by an authorised person when necessary.
The control device (30) of the secure dispensing system, is shaped in such a manner that it is able to fit into the top of the container (10). Embedded contacts between the control device and the container allow direct communication of data between the two parts of the system. The control device is equipped with a communication screen (40), which is able to communicate user specific information to the user. Function keys (50) allow the user to input data or information into the device. A fingerprint scanner (60) is included as part of the control device as a means to measure a users identification. An indication button (70) enables the system to indicate to the user whether specific functions such as delivery of a dose of material from within the container is authorised. For example, the indication button can be programmed to turn green once the user has been authenticated to the control device and the control device has authorised that a dose of the patients medicament may be taken. The indication button can also be programmed to turn red if, for example, the user fails to be authenticated.
The key (80) is shown in situ attached to the control device. The key once inserted into the control device allows a user to be authenticated to the control device. Once authenticated the user is allowed access to certain restricted functions of the system. The key is removable from the control device.
The secure dispensing system described in the present invention could be used to contain a controlled drug such as methadone.
A patient that has been prescribed methadone by their doctor or healthcare provider would take the prescription to their pharmacy. Alternatively the patient's doctor or healthcare provider directly to the pharmacy could send an electronic prescription. Transfer of the prescription in this manner would ensure a secure transfer of the prescription ensuring that the prescription was not diverted in transit to the pharmacy.
The pharmacist would then fill the prescription and supply the drug to the patient.
In order to do this the pharmacist would firstly authenticate himself or herself to a key. This would involve the pharmacist swiping one or more of their fingerprints onto a fingerprint scanner and waiting for the key to confirm that their fingerprints are accepted and they are authenticated to access the restricted functions of the system.
Once this had been achieved the pharmacist would be able to instruct the control device to unlock and open the container. He would then be able to insert the prescribed medicament.
The pharmacist may also need to programme the control device to dispense the drug to the patient in a regime. For example the patient may be prescribed with a dose of 60 ml per day. The pharmacist can programme the control device to dispense the 60 ml dose in increments three times a day between certain hours. In this way the patient would be able to take a 20 ml dose between 7:00 and 8:00. The patient could then access their second dose between 15:00 and 16:00 and their third dose between 23:00 and midnight.
This method of dosing is advantageous as it means that the patient does not have long periods of time between doses.
Once the filling and programming of the system is complete, the pharmacist would authenticate the patient to the device. This would involve swiping the patient's fingerprints across a fingerprint scanner on the container. An RFID tag in the control device would then record the information for use when authenticating a patient before taking a dose is dispensed.
The patient is then able to take the secure dispensing system home and is in consequence able to dispense a dose of medicament according to their pre-programmed schedule.
Changes to the programme may be made if and when necessary by the patients doctor, pharmacist or healthcare provider. The changes can be made either remotely by sending information directly to the patients control device or manually by an authorised and authenticated person.

Claims

1. A secure dispensing system comprising the following:

a container arranged to securely contain a quantity of a material comprising:

an internal locking mechanism to prevent unauthorised dispensing of the material from the container; and

a delivery port to enable dispensing of a quantity of the material from the container,

a control device arranged to enable release of the internal locking mechanism to allow dispensing of the material once authorization of a user has taken place; and

a key to enable a user to access restricted functions of the system,

whereby the operation of the system is controlled by:

authentication of a first user to the key to enable the user to access restricted functions of the system; and

authentication of a second user to the control device to enable dispensing of the material from the container; whereby the authentication means of the user is by measurement of one or more biometric characteristics of the user.

2. A secure dispensing system as claimed in claim 1, wherein the biometric means of authentication is selected from; hand geometry, retina scan, iris scan, fingerprint, facial characteristics, DNA sequence characteristics or voiceprints.

3. A secure dispensing system as claimed in claim 2, wherein the biometric means of authentication is one or more of the users fingerprints.

4. A secure dispensing system as claimed in claim 1, wherein the container is manufactured from a material that is resistant to tamper.

5. A secure dispensing system as claimed in claim 1, wherein the container is manufactured from a material that is bullet-proof.

6. A secure dispensing system as claimed in claim 4, wherein the container is manufactured from a composite material.

7. A secure dispensing system as claimed in claim 6, wherein the composite material comprises aluminium, epoxy resin and silicon carbide.

8. A secure dispensing system as claimed in claim 1, further comprising a valve and pump assembly, which is inaccessible to the system user.

9. A secure dispensing system as claimed in claim 8, wherein the valve and pump assembly is disposable.

10. A secure dispensing system as claimed in claim 8, wherein the valve and pump assembly is arranged in the container to produce an indirect pathway to the delivery port.

11. A secure dispensing system as claimed in claim 1, wherein the delivery port has a valve to prevent material being extracted from the system's delivery port.

12. A secure dispensing system as claimed in claim 1, wherein the container can be opened to allow the contents of the container to be replaced.

13. A secure dispensing system as claimed in claim 1, wherein the control device has means for storing and transmitting data.

14. A secure dispensing system as claimed in claim 1, wherein the control device comprises a display screen.

15. A secure dispensing system as claimed in claim 1, which further comprises means for allowing data input.

16. A secure dispensing system as claimed in claim 1, wherein the control device is equipped with a tamper indicator.

17. A secure dispensing system as claimed in claim 1, wherein the control device can communicate information to the user.

18. A secure dispensing system as claimed in claim 1, wherein the control device is equipped with a biometric authentication device.

19. A secure dispensing system as claimed in claim 18, wherein the biometric authentication device is a fingerprint scanner.

20. A secure dispensing system as claimed in claim 1, wherein the control device is detachable from the container.

21. A secure dispensing system as claimed in claim 1, wherein the key comprises a biometric means of authentication, which must be provided in order to authenticate the user to the key.

22. A secure dispensing system as claimed in claim 1, wherein the key has means for storing and transmitting data.

23. A secure dispensing system as claimed in claim 1, wherein the biometric means of authentication is by identification of one or more of a users fingerprint.

24. A secure dispensing system as claimed in claim 1, wherein authentication of a user to the key enables the user to access specific functions of the system.

25. A secure dispensing system as claimed in claim 1, wherein the different parts of the system are able to communicate with each other.

26. A secure dispensing system as claimed in claim 25, wherein the communication between different parts of the system is achieved by one or more radio frequency identification (RFID) tags.

27. A secure dispensing system as claimed in claim 26, wherein a plurality of RFID tags are able to communicate with one another to authenticate the components of the system.

28. A secure dispensing system as claimed in claim 26, wherein an RFID tag associated with the material contained within the container communicates with an RFID tag reader associated with the container, which in turn communicates with an RFID tag reader associated with the control device, and wherein the dispensing of the material will only occur if the data that is communicated between the parts of the system is authorized by the system.

29. A secure dispensing system as claimed in claim 1, wherein the material to be dispensed is a pharmaceutical product.

30. A secure dispensing system as claimed in claim 29, wherein the material to be dispensed is a controlled drug or a drug of abuse.

31. A secure dispensing system as claimed in claim 30, wherein the controlled drug or drug of abuse is a Class A drug as defined by The Misuse of Drugs Act 1971.

32. A secure dispensing system as claimed in claim 30, wherein the controlled drug or drug of abuse is an opioid.

33. A secure dispensing system as claimed in claim 32, wherein the opioid is methadone or a pharmaceutically acceptable salt or derivative thereof.

34. A secure dispensing system as claimed in claim 34, wherein the opioid is methadone hydrochloride.

35. A secure dispensing system as claimed in claim 1, wherein the system is used to dispense a measured dose of material according to a pre-programmed regime.

36. A secure dispensing system as claimed in claim 35, wherein the measured dose of material can be delivered in increments.

37. A method of securely dispensing a material from a container, said method comprising the steps of;

Authentication of a first user to a key by one or more biometric means of identification;

Communication of the data produced by authentication to a means for analysing the data;

Analysis of the communicated data to determine whether the first user is permitted to access restricted functions of the system;

Access to restricted functions of the system if the first user is authorised;

Authentication of a second user to a control device by one or more biometric means of identification;

Analysis of the communicated data to determine whether dispensing of the material from the container is permitted; and

38. A method as claimed in claim 37, wherein the biometric means of authentication is one or more of the users fingerprints.

39. A method as claimed in claim 37, wherein the key, once authenticated, allows the first user to open the container to enable the contents of container to be replaced.

40. A method as claimed in claim 37, wherein the key, once authenticated, allows the first user to programme the control device to enable dispensing of material according to a regime.

41. A method as claimed in claim 37, wherein the communication of data between the control device and the container is achieved by RFID tags.

42. A method as claimed in claim 37, wherein the material to be dispensed is a pharmaceutical product.