Australian Statistics on Medicines 2001–2002 Stats/Meds2001-02 [09/09] 08/11/04 3:08 PM Page I
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Australian Statistics on Medicines • 2001–2002 Australian Statistics on Medicines 2001–2002 Stats/Meds2001-02 [09/09] 08/11/04 3:08 PM Page i Australian Statistics on Medicines 2001–2002 Stats/Meds2001-02 [09/09] 08/11/04 3:08 PM Page ii Acknowledgments Prepared by John Dudley, Maxine Robinson and Catherine Rostron, of the Drug Utilisation Sub-committee secretariat. We would like to thank the following people for their help in the access and provision of data and information used in this report: •Peter Marlton, Doug Bain and Blazenka Sculac, Department of Health and Ageing • Richard Hill, TGA • Richard Webb, Australian Institute of Health and Welfare © Commonwealth of Australia 2004 ISBN 0 642 82548 3 This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth available from AusInfo. Requests and inquiries concerning reproduction and rights should be addressed to the: Manager, Legislative Services, AusInfo, GPO Box 1920, Canberra ACT 2601. Also published on http://www.health.gov.au/pbs/general/pubs/asm.htm Publications Approval Number: 3535/JN8772 Stats/Meds2001-02 [09/09] 08/11/04 3:08 PM Page iii FOREWORD Comprehensive and valid statistics on use of medicines by Australians in the public domain should be accessible to all interested parties. From the first edition in 1992 until 1999 the Drug Utilisation SubCommittee (DUSC) produced the Australian Statistics on Medicines (ASM) for each calendar year to 1998. In 2002 we presented the annual statistics for 2001 together with the estimates for 1999–2001. This edition presents the statistics for 2002 and 2003. A continuous data set representing estimates of the aggregate community use (non public hospital) of prescription medicines in Australia is a key tool for the Australian Medicines Policy. The ASM presents dispensing data on most drugs marketed in Australia and is the only current source of data in Australia to cover all prescription medicines dispensed in the community. Drug utilisation data can assist the targeting and evaluation of quality use of medicines initiatives, and the evaluation of changes to the availability of medicines. It is also needed for pharmacosurveillance by regulatory and financing authorities and by the Pharmaceutical Industry. Publication of the Australian data also facilitates international comparisons of drug utilisation profiles and encourages international collaboration on drug utilisation research particularly in relation to enhancing the quality use of medicines and health outcomes. Andrea Mant MBBS, MD, MA, FRACGP Chairman Drug Utilisation Sub-Committee iii Stats/Meds2001-02 [09/09] 08/11/04 3:08 PM Page v CONTENTS FOREWORD iii INTRODUCTION vi INFORMATION ON THE AUSTRALIAN STATISTICS ON MEDICINES 1 Drug Utilisation Sub-Committee 2 Drug classification 4 Measurement unit 5 Health Insurance Commission processing 7 Pharmacy Guild survey data 7 Combined database 8 ADVERSE DRUG EVENT REPORTING IN AUSTRALIA 11 HIGHLY SPECIALISED DRUGS PROGRAM 15 Program overview 15 Highly Specialised Drugs Working Party 15 Criteria for selection of Highly Specialised Drugs 15 Supply of pharmaceutical benefits to remote Aboriginal Health Services 17 HEALTH EXPENDITURE TRENDS 19 DRUG UTILISATION TRENDS 21 TABLES IN THE AUSTRALIAN STATISTICS ON MEDICINES 28 References 28 CAVEATS 29 GLOSSARY OF TERMS 30 Weights and measures 31 v Stats/Meds2001-02 [09/09] 08/11/04 3:08 PM Page vi ANATOMICAL THERAPEUTIC CHEMICAL INDEX (ATC) & DEFINED DAILY DOSE (DDD) CHANGES 2001 & 2002 32 Table 1a Estimates of 2001 community prescription numbers and, for PBS-listed drugs, cost (government and patient) 39 Table 1b Estimates of 2002 community prescription numbers and, for PBS-listed drugs, cost (government and patient) 177 Table 2 Community prescription drug use, in defined daily doses (DDDs) per 1000 population/day, for 2000 to 2002 313 ATC INDEX 397 List of Tables Table A: Prescription numbers by ATC groups 21 Table B(a): Top 10 drugs by defined daily dose/thousand population/day, 2001 23 Table B(b): Top 10 drugs by defined daily dose/thousand population/day, 2002 23 Table C(a): Top 10 drugs by prescription counts, 2001 24 Table C(b): Top 10 drugs by prescription counts, 2002 24 Table D(a): Top 10 drugs by cost to Government, 2001 25 Table D(b): Top 10 drugs by cost to Government, 2002 25 List of Figures Figure A: Community utilisation of fluoxetine 9 Figure B: Community utilisation of amitriptyline 9 Figure C: Number of prescriptions by type of service 22 Figure D(a): Top 10 subsidised drugs dispensed in 2001 26 Figure D(b: Top 10 subsidised drugs dispensed in 2002 26 Figure E(a): Top 10 non-subsidised drugs dispensed in 2001 27 Figure E(b): Top 10 non-subsidised drugs dispensed in 2002 27 vi Stats/Meds2001-02 [09/09] 08/11/04 3:08 PM Page vii INTRODUCTION The data contained in the 2001/2002 ASM are drawn from two sources. The first is the Health Insurance Commission records of prescriptions submitted for payment of a subsidy under the Pharmaceutical Benefits and Repatriation Pharmaceutical Benefits Schemes (PBS/RPBS). The second is an ongoing survey of a representative sample of community pharmacies, which provides an estimate of the non-subsidised use of prescription medicines in the Australian community. The usage of prescription medicines dispensed in public hospitals is not available in this report. The units of measurement are the prescription and the defined daily dose per 1000 population per day (DDD/1000/day). The defined daily dose is established by the WHO Collaborating Centre for Drug Statistics Methodology on the basis of the assumed average dose per day of the drug, used for its main indication by adults. The drugs presented in this publication are arranged using the Anatomical Therapeutic Chemical (ATC) classification system. For more detail on this classification and the unit of measurement, please read the chapter ‘Information on the Australian Statistics on Medicines’. The data are presented in two major tables. Table 1 includes 2001 (Table 1a) and 2002 (Table 1 b) community (i.e. subsidised and non-subsidised) prescription numbers, together with the government and patient costs for the PBS-listed drugs only. The cost information for the PBS listed drugs includes a component which estimates the under copayment cost based on PBS experience with that drug. Cost information on the dispensing of drugs not listed on the PBS is not available. Table 2 includes community prescription drug use, in DDDs/1000/day, for the years 2000 to 2002. vii Stats/Meds2001-02 [09/09] 08/11/04 3:08 PM Page 1 INFORMATION ON THE AUSTRALIAN STATISTICS ON MEDICINES In order to work towards the more rational and cost-effective use of medication in society, it is essential to have accurate information on patterns of drug prescription and use. Where this use is found to be inappropriate, drug utilisation data can monitor the impact of educational or regulatory interventions and can guide the interpretation of pharmacoeconomic analysis (1). In Australia community prescriptions(i.e. non-public hospital) are dispensed as private prescriptions or under one of two subsidisation schemes—the Pharmaceutical Benefits Scheme (PBS) and the Repatriation Pharmaceutical Benefits Scheme (RPBS). These schemes were established to provide the general community (PBS) and returned servicemen and women (RPBS) with access to necessary medicinal products, which are affordable, available and of acceptable standards. In 2001 the RPBS was 7.4% of the size of the PBS and in 2002 it was 8.4%. However over 90% of the RPBS prescriptions involved PBS listed drugs in both years. In Australia, a new medicinal drug must gain approval for supply in accord with the requirements of the Therapeutic Goods Act 1989. Approval is also required to extend the indications of an established drug. Applications are dealt with by the Therapeutic Goods Administration and, for prescription drugs, advice is sought from an expert committee, the Australian Drug Evaluation Committee (ADEC). Once a prescription drug is approved for marketing, the company concerned usually applies to have the drug listed on the PBS. This is the national scheme available to the Australian community, for subsidising the cost of pharmaceuticals. Because of the attraction of the scheme to consumers, it is usually necessary for the company to have the drug listed on the scheme for viable marketing to occur. It is the Pharmaceutical Benefits Advisory Committee (PBAC) that recommends what drugs are to be listed on the PBS. Whereas the pre-market evaluation addresses the issues of quality, safety and efficacy, the PBAC considers effectiveness and cost-effectiveness of the product relative to other alternatives. Once listing has been agreed to by the Government, the price of the drug is negotiated with the company by the Pharmaceutical Benefits Pricing Authority. The Authority consists of government, industry and consumer representatives. Under the PBS, general patients pay the cost of a prescription up to a maximum of $20.60 (January 2000 to February 2001) with increases of $21.90 until February 2002, $22.40 until February 2003, and $23.10 until February 2004. Pensioner and concessional patients pay $3.30 per script (January 2000 to February 2001) increasing to $3.50 (Feb 2001 to Feb 2002), $3.60 (Feb 2002 to Feb 2003) and $3.70 (Feb 2003 to Feb 2004). There is a safety net to protect people with high medication needs. Once general patients (and their 1 Stats/Meds2001-02 [09/09] 08/11/04 3:08 PM Page 2 immediate family) have incurred $669.70 in 2001 ($686.40 in 2002 and $708.40 in 2003) of PBS expenditure (indexed) in any calendar year, prescriptions for the remainder of the year cost only the concessional co-payment amount.