WO 2012/048375 PCT/AU2011/001304 EMERGENCY OR )RUJ KT SYSTEM FIELD OF INVENTION 'IThis invention relates to the maintenance of drugs. More particularly, this invention relates t6 the maintenance of drugs to ensure that they are maintained within required 5 temperature ranges. BACKGROUND ART The following references to and descriptions of prior proposals or products are not intended to be, and are not to be construed as, statements or admissions of common general knowledge in the art. In particular, the following prior art discussion does not 10 relate to what is commonly or well known by the person skilled in the art, but assists in the understanding of the inventive step of the present invention of which the identification of pertinent prior art proposals is but one part. Many drugs and other items (which will generally be referred to as drugs herein) can be made up of relatively unstable molecules. The drugs may be temperature sensitive 15 and have an acceptable temperature range within which they remain viable or efficacious. Some drugs denature if they exceed their acceptable range, possibly having serious adverse effects on any patient to which they are administered, whether because they do not perform adequately in their desired affect is reduced or because. they perform differently. Predictability in the perilrmance of drugs is fundamental to 20 efftctive pharmaceutical medicine. With regard to mechanical devices, some resuscitation equipment is adapted to only operate correctly provided it is in its acceptable temperature nmge and this can limit the care that can be given to the patient in question, The problem of maintaining drugs is substantial in ambulance services. Vehicles arc 25 often exposed to extreme temperatures Dirugs may have to be replaced due to their uncertain efficacy. This adds to the cost of drugs to ambulance services and would be unnecessary where drugs which would be fully satisfactory in use need to be replaced as a precaution. 1 WO 2012/048375 PCT/AU2011/001304 It is the object of the invention to ameliorate the problems set out above or at least provide a useful alternative to current practices. STATEMENT OF INVENTION The invention according to one or more aspects is as delined in the independent 5 claims. Some optional and/or preferred features of the invention arc defined in the dependent claims. Tfhe invention may include means associated with drug kits which sense or estimate likely changes in the temperature of the drug or drugs in the kit and provide a visible and/or audible warning if it is likely that the drugs will reach an unacceptable 1 temperature. In another aspect of the invention there is provided monitoring means for a drug kit, which monitoring means senses the temperature, or estimates likely changes in the temperature, of one or more drugs in the kit and provides a visible and/or audible alarm if the drugs reach, or it is likely that the drugs will reach, a temperature outside 15 a prescribed range. It is preferred that, as well as the warning or alarm, the invention further provides temperature modification means in the form of heating and/or cooling means whereby the temperature of the drugs is automatically modified if an unacceptable temperature, either low or high, is, or is likely to be, reached. 20 .In a first application of the invention, the kits are normally held at a fixed, sare temperature and when they arc removed from this condition, data logging means calculate, in association with at least one external parameter, the period during which the drugs in the kit will remain safe and, on the expiration of this calculated time, actuate the alarm. 25 It is preferred that the external parameter used includes at least ambient temperature. Alternatively, the external parameter may include time. The external parameter may be a combination of parameters, such as ambient temperature and time. 2 WO 2012/048375 PCT/AU2011/001304 There is currently no tomiperature monitoring of drugs or equipment in ambulances in Australia, which means there is no reliable way of knowing what conditions temperature sensitive goods have been subject to. That means that there is no way of knowing how many times the drugs For example have heei out of their acceptable 5 temperature range or for how long. The logging of this kind of data allows assessments of individual kits and the removal of possibly inefTective goods and equipment after they have been subject to unacceptable conditions but at the same time, maintaining for service such goods and equipment which have not been subjected to unacceptable conditions. 10 By the usc of this invention, emergency services will have a way of looking at the exact conditions the kits have been subject to and with that information they can remove possibly denatured drigsmedicamcnts with changed and unpredictable properties. drugs with reduced efficacy or ineffective. equipment. This eliminates the risk of having ineffective or dangerous drugs at the scene of an emergency, as they is would have bccn.replaced. At the same time, there will be confidence in the condition of the kits. If they have not been at risk, there is no need for preventative replacement. Also, the information which is recorded gives the users information to help them keep the kits within an acceptable temperature range. In a particularly preferred aspect of the invention, there is provided an emergency or 20 drug kit system having a thermally regulated housing comprising: accss to a cQoTputcr ProccssoT in cowununication vith exteniul temperature measuring means proximal to the housing, a compartment adapted to house an emergency or drug kit containing temperature sensitive itcms; 25 a sensor linked to the computer and adapted to detect the removal of the kit; and an alarm- adapted to be activated after a period calculated by the processor taking into account parameters including the temperature as measured by the external 3 WO 2012/048375 PCT/AU2011/001304 temperature measuring means, the thermal stability properties of the individual items in the kit and the time that the kit has been exposed outside the housing. The sensor may be a remote signal generator adapted to communicate with the housing acting as a monitoring station having temperature monitoring and remote 5 signal generator proximity detection means. The remote signal generator may he an RIt chip and the monitoring station may hc adapted to detect when the kit is remote from the monitoring station and for how long. The kit may further comprise a thermostal to detect the ambient temperature immediately surrounding the kit. The monitoring station may comprise the computer that processes data sent by the 10 remote signal generator, thermostat and a timer, to calculate the risk of exposure of the kit to external temperatures away from the monitoring station and a pre-emptive period at vhich the kit should be rccallcd to the housing. The housing may comprise temperature regulation means for refrigeration and/or heating the compartment in which the kit may be housed between uses. The housing 15 may emit a waning alarm when parameters of unsafe temperatures and/or unsafe exposure time of the kit away from the housing have been met. The kit may comprise temperature regulation means for refrigeration and/or heating that is deployed when the warning alarm has been activated. The drug kit may comprise monitoring means that senses the temperature, or estimates 2o likely changes in the temperature, of one or more drugs in the kit and provides a visible and/or audible alarm if the drugs reach, or it is likely that the drugs will reach, a temperature outside a prescribed range; The monitoring station may he a housing in a vehicle and may be powered by the vehicle's power supply. The monitoring station may comprise an alarm and a thermostat, the alarm adapted to 25 go off when the kit is removed from the monitoring station for a length of time and kept in an ambient temperature whereby the comptiter calculates that the combination of time and temperature parameters have reached a certain trigger value according to a calculation made by the computer. 4 WO 2012/048375 PCT/AU2011/001304 BRIEF DESCRIPTION OF TIlE DRA WINGS Possible and preferred features of the present features of the present invention will now he described with particular reference to the accompanying drawings. However, it is to be understood that the features illustrated in and described with reference to the 5 drawings are not to be construed as limiting on the scope of the invention. h the drawings Figure 1 is a perspective view of a drug kit according to a first embodiment; Figure 2 is a perspective view of an open drug kit according to the first embodiment; Figure 3 is a closer partial perspective view of the drug kit shown in Figure 2; 20 Figure 4 is a perspective view of an open drug and first response kit according to a second embodiment; Figure 5 is a closer partial perspective view of the drug and first response kit shown in Figure 4; Figure 6 is a partial perspective view of the open drug and first response kit from an 15 upper and side perspective; Figure 7 is a perspective view of the drug and first response kit shown in Figure 4 closed and ready for storage Figure 8 is a schematic representation of a temperature control preventative process according to another aspect of the invention; 20o Figure 9 is a schematic representation of a temperature control assessment process according to another aspect of the invention; and Figure 10 is a schematic representation of a vehicle with a cabinet according to another aspect of the invention. DETAILED DESCRIPTION OF THE DRAWINGS 25 In a first embodiment of the invention shown in Figs. 1 - 3. a kit 10 containing temperature sensitive drugs 20 are initially located in an interactive cabinet 30 (see Figs. 8 and 10) which is temperature controlled. lhe cabinet 30 may be housed in a 5 WO 2012/048375 PCT/AU2011/001304 vehicle 50. such as an ambulance. The kit 10 is primarily for storage and carriage of drug ampoules 20 contained in elastic loops 21 that keep the ampoules 20 stable and separated. The walls, floors and lid may he flexible or rigid. The walls, floors and lid may be 5 padded for protection against buffeting and for thermal insulation. The walls 12 and the lid are joined by a zip 18 that provides an openable seal fbr the kit 10. The kit 10 may include an alarm contained in a pocket or zipped compartment or pouch 25. The kit 10 may include a data logger and a transnitter/reciver device to enable communication and exchange of data between the data logger and the cabinet 30. 10 The kit 10 may include a thermostat, a barometer and other parameter sensing devices required to monitor the immediate environment of the kit 10. The data logger 23, the thenrostat and the barometer may be located in the sealed pouch 25 adjacent a material hinge 27 of (he kit 10. However, preferably the data logger 23 is sewn into place in a pouch 29 adjacent the zipped pouch 25.hlie data logger 23 may comprise a 15 small computer processor, RAM and ROM memory and be the size of a small memory stick, having a IJSB connection for connecting to a wire link to a central computer 32 associated with the cabinet 30. Alternatively, the data logger 23 has associated with it a transnitter/receiver device for remote and wireless communication witb the computer 32. The data logger 23 is adapted to periodically (say once every 20 few seconds) log readings of temperature and humidity in the immediate vicinity of the kit 10. Referring to Figures 4 -7, a drug and first response kit 10a is shown. The kit 10a has insulated or padded walls 12 and a floor 14. The upper edge of the walls has a zip 18 or studs that permit the thermally insulated closure of the kit 10 by a lid 16. The zip 25 18 extends around the two side walls 12a and the front wall 12b with a back wall 12c being continuous with the lid 16. The lid 16 may form a flap that is openable so that the whole kit 10a may be opened and laid flat on its floor 14 and the outer surface 36 of the lid 16 so that the contents 20a, such as pads, fluids syringes and ampoules, are easily accessible, whilst being well contained and separated to minimise the risk of 30 spillage and cross-contamination, 6 WO 2012/048375 PCT/AU2011/001304 The kit 1 Oa internally includes numerous sleeves, compartments and pockets 31 for receiving various drugs'20 and other emergency treatment items 20a that separate individual items 20,20a from each other and minimise the risk of cross-contamination and spillage. The material of the walls 12, floor 14 and lid 16 may be flexible or rigid. 5 depending on the degree of bulTeting and abrasion that the kit 10a is likely to be exposed to and is generally non-elastic. The walls 12, floor 14 and lid.16 may include double layers defining an internal space into which thermal insulation may be inserted to improve the thermal insulation properties of thc kit I 0a. With reference to Figs. 8 - 10, when the kit I0a is taken out of the cabinet 30 to be 1o used, a signal is logged by a computer 32 associated with the cabinet 30 thereby noting the kit's 10 removal. '[his may be in the form of a sensor loop that is completed on removal of the kit 20a. 'The cabinet 30includes weight sensors that are used to calculate the kit's 10a thermal mass and this information is collated and stored in the computer 32. 15 The computer 32 also has stored within it, or has periodic access to, a database of drug proportics including information in relation to safe temperature and/or humidity ranges for each drug. 'The computer 32 stores a safe temperature range for cach drug container in the kit.0 a and the kit's thermal mass, which might be entered into the computer 32 from a data specification sheet, or may be obtained by a set of scales 20 installed in the cabinet 30 on which the kit 1 Oa rests, The computer applies an algorithm to calculate relative variable factors such as variations in temperature outside the safe range and time outside that range, so that ambient temperature data over the period that the kit 1 Oa is removed from the cabinet 30 is used to calculatewhen the kit 1Oa should be returned to minimise the risk of 25 spoiling or denaturation of the drugs 20. So the removal of the kit 1 Oa begins a timing process carried out by the computer 32. A thermostat 11 may be attached to the kit 10a. The thermostat 11 may be radio linked to the computer 32 via the data logger 23 and transmitter. The kit 10a may include a recording unit 14 to periodically record the temperature around the kit 1 Oa, the 7 WO 2012/048375 PCT/AU2011/001304 recording unit 14 optionally forming part of the data logger 23. The recording unit 14 may be radio linked to the computer 32.. Alternatively, a thermostat 52 is located in, in or in association with the vehicle 50 and is linked to the cabinet computer 32 to periodically record the ambient temperature. 5 Preferably. the cabinet. 30 includes an external thermostat 34 located on the outer surface 36 thereof that measures the ambient temperature in the vehicle 50 and sends. temperature data to the computer 32. The thermostats S4,52 are preferably located in different positions, thermostat 34adapted to measure temperature outside the vehicle and thermostat 52 adapted to 10 measure the temperature adjacent and external to the cabinet 30. By taking into account the outside temperature, the computer may be used to send an alert or message to a user as to when the kit 10a is at risk of being exposed to potentially damaging temperature relative to the time of exposure, these being the combination of parameters most likely to potentially adversely affect the drugs 20 located in the kit 15 I0a. An alarm 38 is provided on the cabinet 30 that is activated by the computer 32 on exposure of the drugs to conditions that exceed the parameters of safe drug 20 storage. The alarm 38 might alternatively be associated with the vehicle 50, for example the alarm 38 could be provided by the vehicle 50 horn. The alarm 38 may additionally or 20 alternatively include a visual cue such as a flashing light 40, fbr example where patient welfare is dependent ona loss noisy environment. By sounding or setting off the alarm 38, the user is alerted to take action to restore the kit 10a to the cabinet 30, to retrieve a replacement kit 1 Oa from the cabinet 30, or to discard the affected drugs 20 and to replace them in the kit I 0a. 25 The remedial action carried out by a user may be to return the kit I0a to the temperature control cabinet 30 so that its temperature is reduced to a safe level after -which, if the kit 10a is still likely to be required, it could be removed from the cabinet 30 and re-used. Alternatively, at this time a cold pack 42 within the kit 1Oa could be actuated to ensure that the temperature therein is reduced. The cold pack 42 may be a 8 WO 2012/048375 PCT/AU2011/001304 disposable non-refrigerated portable instant ice compress that may be activated, for example, by manually breaking, squeezing. shaking the contents to initiate the cooling of the substance. The thermostat 11,34,52 may be a digital device capable of feeding back a digital 5 signal recordable by the computer 32 or data logger 23. The computer 32 may include a display, such as an LTJD display 33, that indicates the predetermined and acceptable temperature range for the contents 20 of the kit 10a, the internal temperature of the kit IOa and the ambient temperature of the kit's IO immediate surrounds. The computer 32 may include a simple electronic sounding device 38 and LED flash 10 display 40 to alert the user when the preferred time and temperature parameters approach or are exceeded. Referring to Fig. 9, in an alternative embodiment, a thermo-fecedback system 60 is located within a drug kit l06. The kit 10b has a temperature sensitive device such as a thcrmometer/thermostat 62 and temperature control device 64 therein or built in to the 15 side thereof as shown, which temperature sensitive device 62 is preset to operate at a temperature below the maximum and/or above the minimum safe temperatures for the particular temperature sensitive items 20,20a in the kit 10b. Once the temperature sensitive device 62 detects that the temperature has entered the range of unsafe temperatures, the sensing device 62 alerts the user to take action to prevent the 20 sensitive items 22 being rendered ineffective. If required. the warning about the risk of the kit 10, 1Oa, Ob, and thus its contents 20,20a, reaching a prodotermined dangerous temperature could include both a. time and a temperature, range to ensure that if one fails or does not give an indication of danger of damage, the other one does, 25 Different substances, particularly drugs 20, have dil1erent tolerances to exposure to excessively high or low temperatures. And time of exposure can also be a critical factor as to whether the chemical or material structure of the substance 20,22 has been changed. Denaturation of some stabilised pharmaceuticals can occur at temperatures as low as 40'C and temperatures approaching this may adversely affect the efficacy of 9 WO 2012/048375 PCT/AU2011/001304 nature of drugs 20 if exposed for an extended period of time. Indeed, some protein based pharmaceuticals are best maintained at temperatures just above 0'C, for example. up to 4"C. However, emergency kits 10,1 Oa,1 Ob will generally include stable pharmaceutical compounds that are unaffected at temperatures in a range not 5 exceeding 40'C, The operation of the computer 32 and the data logger 23 involve two aspects: 1) Preventative measures; and 2) Assessment of the real situation that occurs. In the preveitativc measure the cabinet computer 32 senses, records or calculates: 10 e the departure of the kit 10,10a, lob from the cabinet 30; * the external or ambient temperature; * the thermal mass of the kit 10,10a,10b; * the temperature ranges of the drugs 20 in the departed kit 10,1Oa,Ob. With this information the computer 32 executes calculations to determine at what time 15 the drugs 20 arc likely to be unacceptably exposed in an environment outside temperature range and sounds or sets of the alarm 38,40. The user is then required to act on this alarm 38,40 and to ensure that the kit 10,10a,lob returns to the temperature controlled environment of the cabinet 30. As this is not always possible, for example, in an emergency, it is preferablc that an 20 assessment of the actual conditions that the drugs have been under is made to determine whether any of the drugs 20 are no longer safe or efficacious to use. '.This aspect of the assessment process looks at what actually happened in terms of the drugs 20 in the kit 10,1 Oa,1 Ob being exposed to temperatures outside the safe range. 'The data logger 23 in the kit 1 Oa is a device that reads the environmental Icvels of 25 humidity and temperature. As it is in the kit 1Oa with the drugs 20 it may be used to determine what the drugs environmental conditions the drugs 20 were actually subjected to. At the end of the day (or whenever the ambulance or other maintenance 10 WO 2012/048375 PCT/AU2011/001304 scrvicc) decides is a good cycle for drug 20 renewal, the data logger 23 is corrected to a computer, optionally the computer 32, that has software installed to analyse the data and to determine which drugs are passed their "usc-by" date. The software takes into account the environmental data, includes relevant data as to 5 what drugs 20 are in the kit 10,10a,10b in question; refers to a database of all drugs and their safe temperature ranges; and determines which drugs 20 are in danger of having been spoiled, denatured or otherwise deleteriously alTected. The program will report to the user which drugs to in the kit 10,10a,10b should be replaced. Referring again to Fig. 5, the kit 10a may include a pouch 29a to alternatively house 10 the data logger 23, thermostat 11, data recorder 13. The kit may include an internal compartment to store the cold pack 42. Fig. 6 shows a side wall 12a of the kit 1Oa that is padded for thermal and harrier insulation. Returning to Figs. 8 and 10, the cabinet is a portable thermally controlled device ideally suited to running off the power of a vehicle. However, the skilled person will 15 appreciate that the cabinet may be powered by ainy suitable means including independent battery 1DC power, mains AC power and the like, and thereby might he permanently installed or temporarily transported to a work site or crisis zone such as a disaster area or hospital, temporary or permanenLt. As schematically illustrated, the cabinet 30 houses one or more kits 10,1Oa,lOb in a 20 thermally controlled internal space 37 that preferably has a thermally insulating door or curtain to conserve energy. Typically. the cabinet will be refrigerated for hot climates and heated for cooler climates. Preferably, the cabinet includes reverse cycle air conditioning to effectively regulate humidity and temperature irrespective of the prevailing climate or season. 25 The computer 32 stores the kit's 10a individual history and properties of thermal mass and contents 20a. As the kit 1Oa is removed from the cabinet 30, the kit's I0a time of exit, is logged as having exited. External temperatures are monitored throughout the kit's absence from the cabinet 30. The cabinet 30 may he a solid construction made of similar material to a fridge or car fridge with thermally insulated walls and doors. 11 WO 2012/048375 PCT/AU2011/001304 The cabinet 30 is preferably mounted in the vehicle cabin as a fixed installation and connected to the vehicle's 50 power systems. When the kit 1Oa has been absent for a calculated period of time taking into account the factors of humidity and external tcnperature, the alarm 38,40 goes off whereby to alert the user. s With reference to Fig. 9. the operation of the data logger 23 of a removed kit I Ob is illustrated. The data logger 23 draws data on the environmental, conditions frorn the temperature sensitive device such as thermostat 62 and stores this data in a recording device 13, On the kit's 10b return to the cabinet 30, the computer 32 is linked to the data logger 10 23 by a USB connection, radio, wireless, blue ray or other data communication means 37 and the data recorder with the data logger 23 is transferred to the computer 32. The computer 32 contains software that takes into account information from a drug database pertaining to safe temperature ranges or other relevant parameters, the data from the data logger 23 is collated and individual drugs contained in the kit I Oa 15 calculated to be at risk of spoiling are determined and identified on (he display 33 or may be displayed remotely at an administrative station (not shown). The user is issued with a list of the drugs 20 to be replaced. Reference numerals used in the drawings arc listed below: Ref No. Description Ref No. Description., 10, Drug kit, drug and first response kit 12, 12a-c Kit walls, side, front and rear walls 10a,10b 20, 20a Temperature sensitive drugs, tems 14 Kit floor_ - , 30 Cabinet 16 Kit lid 50 Vehicle 18 Zip or studs 32 Computer 21 Elastic loops 11 Kit thermostat 23 Data logger 13 Recording unit 25 Zipped pouch or compartment 34 Cabinet thermostat 27 Material hinge 36 Kit outer surface 29,29a Sewn or zipped pouch 38 Alarm 31 Compartments and pockets 40 Flashing light 33 Computer display 52 Vehicle thermostat 60 Kit with thermo-feedback system 60 Thermto-feedback system 35 Compartment 62 Thermostat 37 Thermally controlled space 64 Tremlperature control device 39 Sensor 39 12 WO 2012/048375 PCT/AU2011/001304 Whilst we have described herein particular arrangements of the system of the invention, it is to be appreciated that these are purely exemplary. For example, the cabinet could itself he portable and self contained arid not be physically attched to the ambulance. Under such an arrangement, the warning device would be in or on the 5 cabinet. Alternatively, a radio signal could be forwarded to the ambulance, or even to a third party, to cause operation of an alarm. Any and all such modifications are deemed to be within the scope of the invention. Throughout the specification and claims the word "comprise" and its derivatives are intended to have an inclusive rather than exclusive meaning unless the contrary is 1o expressly stated or the context requires otherwise. That is, the word 'comprise" and its derivatives will be taken to indicate the inclusion of not only the listed components, steps or features that it directly references, but also other components, steps or features not specifically listed, unless the contrary is expressly stated or the context requires otherwise. 15 It will be appreciated by those skilled in the art that many modifications and variations may be made to the embodiments described herein without departing from the spirit and scope of the invention. Orientational terms used in the specification and claims such as vertical, horizontal, lop, bottom, upper and lower are to be interpreted as relational and are based on the 20 premise that the component, item, article, apparatus, device or instrument will usually be considered in a particular orientation, typically with the lid ofthe kit or the top of the cabinet uppermost. Computer, data and information communication by links includes physical wire links. and wireless links, including RF or blue chip communication means. 25 13