Commonwealth Department of Health and Ageing Australian Statistics on Medicines 1999–2000 © Commonwealth of Australia 2003 ISBN 0 642 82184 4 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. Publications Approval Number: 3183 (PA7270) 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. It is pleasing indeed to be able to present these again this year, with the inclusion of estimates for the years since the last edition. 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 CONTENTS FOREWORD iii INTRODUCTION 1 INFORMATION ON THE AUSTRALIAN STATISTICS ON MEDICINES 2 Drug Utilisation Sub-Committee 3 Drug classification 5 ATC system main groups 6 Measurement unit 6 Health Insurance Commission processing 8 Pharmacy Guild survey data 8 Combined database 9 ADVERSE DRUG EVENT REPORTING IN AUSTRALIA 12 HIGHLY SPECIALISED DRUGS PROGRAM 16 Program overview 16 Highly Specialised Drugs Working Party 16 Criteria for selection of Highly Specialised Drugs 16 Supply of pharmaceutical benefits to remote area Aboriginal Health Services 18 HEALTH EXPENDITURE TRENDS 20 DRUG UTILISATION TRENDS 22 TABLES IN THE AUSTRALIAN STATISTICS ON MEDICINES 29 References 29 CAVEATS 30 GLOSSARY OF TERMS 31 Weights and measures 32 ANATOMICAL THERAPEUTIC CHEMICAL INDEX (ATC) & DEFINED DAILY DOSE (DDD) CHANGES 1999 & 2000 33 v Table 1a 1999 community prescription numbers, together with government and patient costs for PBS-listed drug 39 Table 1b 2000 community prescription numbers, together with government and patient costs for PBS-listed drugs 183 Table 2 Community prescription drug use, in defined daily doses (DDDs) per 1000 population/day, for 1998 to 2000 321 INDEX BY ATC CODE 405 vi List of Tables Table A: Prescription numbers by ATC groups 22 Table B(a): Top 10 drugs by defined daily dose/thousand population/day, 1999 23 Table B(b): Top 10 drugs by defined daily dose/thousand population/day, 2000 24 Table C(a): Top 10 drugs by prescription counts, 1999 24 Table C(b): Top 10 drugs by prescription counts, 2000 25 Table D(a): Top 10 drugs by cost to Government, 1999 25 Table D(b): Top 10 drugs by cost to Government, 2000 26 List of Figures Figure A: Community utilisation of fluoxetine 9 Figure B: Community utilisation of amitriptyline 10 Figure C: Number of prescriptions by type of service 23 Figure D(a): Top 10 subsidised drugs dispensed in 1999 26 Figure D(b): Top 10 subsidised drugs dispensed in 2000 27 Figure D(c): Top 10 non-subsidised drugs dispensed in 1999 27 Figure D(d):Top 10 non-subsidised drugs dispensed in 2000 28 vii INTRODUCTION The data contained in the 1999/2000 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 1999 (Table 1a) and 2000 (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 1998 to 2000. 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 1999 the RPBS was 7.8% of the size of the PBS and in 2000 it was 8.1%. 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 $20.30 (Jan 1999 to end Jan 2000) which increased to $20.60 until February 2001. Pensioner and concessional patients pay $3.20 per script (Jan 1999 to end Jan 2000) increasing to $3.30 (Feb 2000 to Feb 2001). There is a safety net to protect people with high medication needs. Once general patients (and their immediate family) have incurred $620.60 in 1999 ($631.20 in 2000) of PBS expenditure (indexed) in any calendar year, prescriptions for the 2 remainder of the year cost only the concessional co-payment amount. Once pensioners and concessionals have incurred $166.40 in 1999 ($171.60 in 2000) of expenditure (indexed) in the calendar year, they receive all remaining prescriptions free of charge for the remainder of the calendar year. Patients may also be required to pay a surcharge where the doctor prescribes a more expensive brand of an item, when there are cheaper, equivalent brands of that item listed on the PBS. As the general patient copayment rises, the dispensed price of many of the cheaper medications falls under this level. In such cases the patient pays the full price and no claim for payment is transmitted under the PBS. In 1999 under copayment general prescriptions represented around 17% of all community prescribing. In 2000 under copayment general prescriptions represented 16% of all community prescribing. There are also many drugs that are not listed on the PBS or RPBS and are available only on private prescription with the patient paying the full cost (6.5% of community prescriptions in 1999 and 2000). As well as a variety of ways under which prescribing may be effected, there has been no uniformity in Australia in the drug codes that are used to record prescribing and these factors have complicated previous attempts to monitor national trends in this country (2).