1. Implementation of NDS 5.0 an overview of the Australian Experience

2. Currently: The Commonwealth Department of Health and Ageing (Australia) has used a custom designed mainframe database system (based on ADABAS) over the last 10 years to: Issue import and export licences, import and export permits, To track domestic stock movements of narcotic and psychotropic drugs and Collect statistics for reporting to the INCB

3. This system functions as two parallel databases - called DRUMS and IEDRUMS DRUMS – Drugs Monitoring System – for the tracking of in excess of 30,000 domestic stock movements per week of controlled substances (down to consumption level). IEDRUMS – Import/Export Drugs Monitoring System – for the issuing licences and permits for import and export of narcotics, psychotropics and precursor substances. Collection of statistics for quarterly and annual reports to the INCB (Reports A, A/P, C & P)

4. Disadvantages of the current mainframe system include: Manual manipulation of data required for preparation of all reports to INCB DRUMS and IEDRUMS are not functionally linked – manual links must be maintained (has implications for reliable reconciliation of import / export figures with domestic consumption and manufacturing data for INCB Report C) Limited querying and reporting functionality – lacks flexibility! Limited data extraction capabilities – requires intercepts of “dump” files Text based interface – no Graphical User Interface! Continual “fixes” are required to cope with increasing numbers of transactions Departmental IT outsourcing arrangements make for costly maintenance and limited development benefits.

5. Why did we need to change? Changes in standard technology Increasing administrative workloads Greater flexibility required to meet changing needs of stakeholders Mainframe applications will be phased out by the Department by 2005/6/?…

6. Anticipated benefits of NDS: Decreased amount of manual keying (less duplication of effort) Little manual manipulation and data checking required for generation of reports to INCB Opportunities for data cleansing during transition – leading to less errors ! Opportunities for improved communication and service to clients / stakeholders Opportunities for systems integration with Australian Customs Service, State and Territory Health Agencies, Federal and State law enforcement agencies Improved communication.

7. Some considerations in choosing between NDS version 4.0 and 5.0: As with many other countries Australia controls not only those substances subject international control under the UN Drug Treaties but also some other substances, such as steroids and antibiotics. The required enhancements for implementation of NDS Version 4.0 by Australia were divisible into two categories: those for internationally controlled substances and those for non-internationally controlled substances.

8. For internationally controlled substances: Standard licence and permit conditions need to be applied to particular substances or importers / exporters eg. “Goods must not be stored at the importer’s address but delivered directly to …” “Goods permitted hereon are for use in laboratory analysis only” “The importer must notify Australian Customs Service of the arrival time and flight number at least 12 hours prior to arrival of the goods” [for pseudoephedrine raw material]

9. For internationally controlled substances: less importantly View addresses via the permit authorisation screen NDS 5.0 has this feature Flag exports which require corresponding imports permits for Schedule III and IV psychotropic substances NDS 5.0 has this feature Make competent authority an optional field in import screens NDS 5.0 has this feature Permit authorities to choose if error messages can be over-ridden NDS 5.0 has this feature

10. Requirements for substances not under international control? capacity to print different permit types for different groups (eg anabolic steroids) NDS 5.0 has this feature ! substance master file to include additional parameters which can be turned off (eg need for estimates, licences). NDS 5.0 has this feature !

11. The inescapable conclusion was: to install NDS version 5.0 This has involved: construction of master files generation of customised reports. development of new data reporting protocols for domestic stock movements Development of add on module to upload bulk domestic stock movement and manufacturing data some customisation of input parameter labels setting up security and access privileges staff training

12. NDS 5.0 Implementation Construction of master files - of particular importance were the Establishment and Preparation master files Establishment master files - constructed by migration and cleanup of existing data in Mainframe. Preparation Master Files - constructed by association of existing Mainframe masters and the NDS Substance Master file. All goods for which permits are issued were defined as preparations this includes raw materials, bulk and packaged dosage forms The custom numbering scheme used in Mainframe was retained as the user defined numbering scheme in NDS. This numbering scheme is based on a three tier system which has advantages for the consistent tracking of domestic and international stock movements.

13. Format is: XXX-XXX-XXX where first three digits designate the base substance: eg. 015 is morphine 010 is fentanyl second three digits designate the dosage form: eg. 015-023 is morphine sulphate 1mg/mL, 1mL ampoules third three digits - designate the packsize used only for domestically tracked goods: eg. 015-023-010 is morphine sulphate 1mg/mL, 1mL ampoules, pack of 10 This numbering scheme has the advantage that quantities of domestically tracked goods can be quantified by a single field (ie quantity) For non-domestically tracked stock the numbering scheme is based on the use of six digits only - multiple packsizes may be associated by used of the “packsize” field available in NDS 5.0

14. NDS 5.0 Implementation Generation of Custom Reports - some 20 customised reports have been deployed via Crystal Reports, including licence and permit printing functions. Import and Export permits have also been implemented using the VBA features of Microsoft Word Development of new data reporting protocols for domestic stock movements - a new reporting requirement standard was developed for reporting establishments with the aim of minimising the impact of NDS data requirements on reporting establishments. A copy of these data reporting requirements will be made available during this meeting A template for data reporting by reporting establishments has also been developed and is available at: www.health.gov.au/tga/docs/html/export/stockmov.htm

15. NDS 5.0 Implementation Development of add on module to upload bulk domestic stock movement and manufacturing data - an additional module was custom built using PowerBuilder (the same software in which the NDS frontend is written). This module enables the bulk uploading and archiving of domestic stock movement data in CSV format into NDS. Various data integrity checks are performed by this module for missing or incorrect entries. A detailed description of this module will be made available during this meeting, and the updated source code for this module will be provided to the UNDCP software development team shortly.

16. Next? Implement - to date some 350 import and 350 export permits have already been issued for 2003 - these must be entered into NDS once changeover is complete Train and support staff - this will be an interactive process involving all team members to redefine workflow practices to leverage maximum efficiencies from NDS Maintenance and further development - ongoing IT support arrangements will need to be implemented. Australia acknowledges and supports the need for continued improvement of NDS if it is to remain the World Preferred software solution. The mechanism for achieving this will need to be seriously considered by the ever-growing user group.