Australian Statistics 
on Medicines 
2003
Acknowledgments
Prepared by John Dudley, Maxine Robinson and Penny Main, of the Drug Utilization 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 and Mick Turner, Department of Health and Ageing
•	Kerri Mackay, TGA
•	Rebecca Bennetts, Australian Institute of Health and Welfare

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 Utilization Sub-Committee (DUSC) produced the Australian Statistics on Medicines (ASM) for each calendar year to 1998. In 2002 we presented the annual statistics for 1999 and 2000 and in 2003 we presented the annual statistics for 2001 and 2002. This edition presents the annual statistics for 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 Australia’s National 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 Utilization Sub-Committee

CONTENTS
FOREWORD	iii
INTRODUCTION	1
INFORMATION ON THE AUSTRALIAN STATISTICS ON MEDICINES	3
	Pharmaceutical Benefits Advisory Committee	4
	Drug Utilization Sub-Committee	5
	National Medicines Policy	5
	Drug classification	6
	Measurement unit	8
	Health Insurance Commission processing	9
	Pharmacy Guild survey data	10
	Combined database	11
Adverse drug event reporting in Australia	13
Highly specialised drugs program	16
	Program overview	16
	Highly Specialised Drugs Working Party	16
	Criteria for selection of Highly Specialised Drugs	17
	Supply of pharmaceutical benefits to remote Aboriginal Health Services	19
	Expenditure	20
Health expenditure trends	21
Drug utilisation trends	23
Tables in the Australian Statistics on Medicines	28
	References	28
CAVEATS	29
GLOSSARY OF TERMS	30
	Weights and measures	31
ANATOMICAL THERAPEUTIC CHEMICAL INDEX (ATC) 	32
AND DEFINED DAILY DOSE (DDD) CHANGES 2003
Table 1	Estimates of 2003 community prescription numbers and,	35
for PBS listed drugs, cost (government and patient)
Table 2	Community prescription drug use, in defined daily doses	171
(DDDs) per 1000 population/day, for 2001 to 2003
INDEX BY ATC CODE	255
List of Tables
Table A:	Prescription numbers by ATC groups	23
Table B:	Top 10 drugs by defined daily dose/1000 population/day, 2003	25
Table C:	Top 10 drugs by prescription counts, 2003	26
Table D:	Top 10 drugs by cost to Government, 2003	26
List of Figures
Figure A:	Community utilisation of fluoxetine	11
Figure B:	Community utilisation of amitriptyline	11
Figure C:	Number of prescriptions by type of service	24
Figure D:	Top 10 subsidised drugs dispensed in 2003	27
Figure E:	Top 10 non-subsidised drugs dispensed in 2003	27

INTRODUCTION
The data contained in the 2003 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 to in-patients in public hospitals is generally not available in this report. The usage of prescription medicines to out-patients and discharged patients in one state of Australia is included. It is planned that all out-patients and discharged patients will receive PBS subsidised prescriptions in the future.
The units of measurement are the prescription and the defined daily dose per 1000 population per day (DDD/1000 population/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 2003 community (i.e. subsidised and non-subsidised) prescription numbers, together with the government and patient costs for drugs PBS listed and subsidised by the Australian Government only. Cost information on the dispensing of drugs not listed on the PBS and drugs that are PBS-listed but for which no subsidy is claimed from the Australian Government is not available. Table 2 includes community prescription drug use, in DDDs/1000 population/day, for the year 2003.

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 either 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 2003 the RPBS was 7.4% of the size of the PBS. However over 90% of the RPBS prescriptions involved PBS listed drugs.
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 (TGA) 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.
The Pharmaceutical Benefits Advisory Committee (PBAC) makes recommendations to the Australian Government about what drugs should 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 a drug has been recommended for listing on the PBS by the PBAC, the Pharmaceutical Benefits Pricing Authority (PBPA) negotiates the price paid with the company. The PBPA consists of government, industry and consumer representatives. After agreement is reached, the Australian Government considers the advice of both the PBAC and the PBPA and makes a decision on whether the drug should be listed on the PBS. 

Under the PBS, general patients paid the cost of a prescription up to a maximum of $22.40 from February 2002 to February 2003 rising to $23.10 until February 2004. Pensioner and concessional patients paid $3.60 per prescription from February 2002 to February 2003 rising to $3.70 to February 2004.
In addition, there is a safety net to protect people with high medication needs. Once general patients (and their immediate family) incurred $708.40 in 2003 of PBS expenditure (indexed), prescriptions for the remainder of 2003 cost only the concessional copayment amount. Once pensioners and concessionals incurred $192.40 in 2003 of expenditure (indexed) 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 2003, under copayment general prescriptions represented around 15% 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 (7.3% of community prescriptions in 2003).
Pharmaceutical Benefits Advisory Committee
The Pharmaceutical Benefits Advisory Committee (PBAC) is an independent statutory body established on 12 May 1954 under section 101 of the National Health Act 1953 to make recommendations and give advice to the Minister about which drugs and medicinal preparations should be made available as pharmaceutical benefits. No new drug may be made available as a pharmaceutical benefit unless the Committee has so recommended. 
The Committee is required by the Act to consider the effectiveness and cost of a proposed benefit compared to alternative therapies. In making its recommendations the Committee, on the basis of community usage, recommends maximum quantities and repeats and may also recommend restrictions as to the indications where PBS subsidy is available. When recommending listings, the Committee provides advice to the PBPA regarding comparison with alternatives or their cost-effectiveness. 

Drug Utilization Sub-Committee
In 1988, PBAC convened the Drug Utilization Sub-Committee (DUSC) to assist it in making recommendations for listings on the PBS. Its terms of reference are:
–	To develop and advise on the mechanisms for the collection and analysis of comprehensive data on drug utilisation in Australia and to advise on the interpretation of these data.
– 	To advise PBAC on changes in drug utilisation patterns as a consequence of changes in drug availability or restrictions on drug use and to review the utilisation of drugs or therapeutic groups of drugs, including expenditure impacts within the PBS.
–	To identify potential health problems and benefits related to patterns of drug utilisation and to evaluate policy and other interventions related to the use of drugs.
–	To facilitate and promote the dissemination of information on drug utilisation.
– 	To conduct international comparisons of drug utilisation by interaction with appropriate international bodies.
– 	To contribute to educational initiatives which promote the quality use of medicines.
National Medicines Policy
In 1992, the Australian Government endorsed a National Medicines Policy to meet medication and related service needs in such a way that optional health outcomes and economic objectives are achieved. Three of the four components of the National Medicinal Drug Policy are strongly linked to the role of DUSC by their common goals and membership. These are:
(1)	The availability of medicines which meet appropriate standards of quality, safety and efficacy while allowing the introduction of new products to the Australian market in a timely manner.
	This is the primary responsibility of the Therapeutic Goods Adminstration and its advisory committees, the Australian Drug Evaluation Committee (ADEC) and the Adverse Drug Reactions Advisory Committee (ADRAC). ADEC provides independent scientific advice to the Australian Government within the policy framework of the time, whereas ADRAC is responsible for monitoring ongoing drug safety in the post-marketing phase.
(2)	The provision of timely access to the medicines that Australians need, at a cost that individuals and the community can afford.
	This is the primary role of the PBS and RPBS. The relevant advisory committee, PBAC, makes recommendations on drugs registered for marketing in Australia that are to be subsidised by the Government on the basis of comparative effectiveness and 
cost-effectiveness.

(3)	The achievement of high quality use of medicines by consumers and health care providers. The National Strategy for Quality Use of Medicines set out the approach and principles which promote the concept that doctors, pharmacists, nurses and consumers all have a role to play in ensuring that medicines are used wisely.
The Pharmaceutical Health and Rational Use of Medicines (PHARM) Committee that provides the Australian Government with advice on pharmaceutical education and other aspects of the quality use of medicines. In addition, the National Prescribing Service (NPS) is a non-profit, incorporated organisation independent of government and the pharmaceutical industry that supports national coordinated approaches to quality use of medicines by providing independent information to health professionals and consumers.
(4)	The fourth component of the National Medicines Policy is the maintenance of a responsible and viable medicines industry. This is largely carried out through the Pharmaceutical Industry Investment Program which is administered by the Department of Industry, Science and Resources.
The continuing development and implementation of the National Medicinal Drug Policy is coordinated by the Australian Pharmaceutical Advisory Council (APAC), which includes representation from all the major groups involved in pharmaceutical issues in Australia. APAC has a broad charter to develop, promote, influence and assist in the implementation of the National Medicines Policy in Australia.
Historically, the range of ways that prescribing may be effected and the lack of uniformity in drug codes complicated attempts to monitor national trends in this country. (2) DUSC have sought to address these problems through the development of a comprehensive database on community prescription drug use, linked by a uniform structured drug code and an adequate unit of drug utilisation measurement.
Drug Classification
DUSC and the Department of Health and Ageing have adopted the Anatomical Therapeutic Chemical (ATC) code as recommended by the World Health Organization (WHO). It has been a goal of WHO to have an internationally accepted classification for presenting and comparing drug usage data. In 1981 the WHO established a central body responsible for coordinating its use—the WHO Collaborating Centre for Drug Statistics Methodology, which is located in Norway.
The ATC code itself is a structured 7 digit alpha-numeric code with 5 levels that classifies drugs according to their site of action and therapeutic and chemical characteristics.
The first level of the code is the anatomical main group (there are 14 anatomical main groups); the second and third levels are for the therapeutic main group and subgroup, with a 4th level being either a chemical or therapeutic subgroup and the 5th level the actual chemical substance.

The five levels thus are:
1	anatomical main group
2	therapeutic main group
3	therapeutic subgroup
4	chemical/therapeutic subgroup
5	generic drug name
Indomethacin, for example, has the following code: M 01 A B 01.
M denotes	the musculoskeletal system
01	anti-inflammatory and anti-rheumatic products
A	non steroidal
B	acetic acid derivative
01	indomethacin
ATC system main groups:
The 14 anatomical main groups of the ATC code are listed below.
A	Alimentary tract and metabolism
B	Blood and blood forming organs
C	Cardiovascular system
D	Dermatologicals
G	Genitourinary system and sex hormones
H	Systemic hormonal preparations, excl. sex hormones
J	General anti-infectives for systemic use
L	Antineoplastic and immunomodulating agents
M	Musculoskeletal system
N	Central nervous system
P	Antiparasitic products
R	Respiratory system
S	Sensory organs
V	Various

Regular revisions of the ATC system are undertaken by the WHO centre together with the Nordic Council on Medicines. They receive expert advice from an advisory board and an established procedure exists to manage requests for new classifications and to regularly review the current structure.
Although the ATC code extends to the generic drug level it does not identify dosage forms, pack sizes, strengths or brands.
Measurement Unit
The international unit of drug utilisation adopted by the DUSC to accompany this coding system is the defined daily dose (DDD) per thousand of the population per day. The defined daily dose is established by the Nordic Council on Medicines and the WHO Drug Utilisation Research Group on the basis of the assumed average dose per day of the drug, used for its main indication by adults. (3)
Use of the DDD allows for comparisons of drug utilisation independent of differences in price, preparation and quantity per prescription. It also allows comparison of the use of drugs in different therapeutic groups and between regions and countries. Expressing drug use in DDDs/1000/day allows the aggregation of data for those drugs which have differing daily doses. However the DDD is only a technical unit of use and does not necessarily reflect the recommended or average prescribed dose in Australia.
The DDD/1000/day figure is calculated from prescription data. All prescriptions submitted in Australia each year to the Health Insurance Commission for payment of a subsidy are surveyed and the actual average quantities dispensed are computed for each strength and dose form of a preparation. The DDD/1000 population/day for each of these items is then calculated as:
N x M x Q x 1000
DDD x P x D
Where: 
N is the number of prescriptions dispensed in the year.
M is the mass of each dose (e.g. in milligrams or grams and needs to be expressed in the same unit as DDD).
Q is the average dispensed quantity per prescription.
P is the mid year Australian population for the year of data collection.
D is the number of days in the year.
The DDD/1000/ can be calculated over other time periods such as monthly or quarterly.
For PBS items the mass amount (M) is the amount of active drug contained in an individual dose unit e.g. tablet, capsule, suppository etc. Non-PBS items are estimated from a Pharmacy Guild/Amfac survey (see below). Because the data from the survey does not include quantity information, the mass amount for non-subsidised items is the total amount of active drug contained in the pack.
For prescriptions forwarded for subsidy, the average quantity dispensed (Q) is available from the HIC data. For prescriptions that are priced under the general copayment, this quantity is assumed to be the average quantity of the subsidised prescriptions for that drug (i.e. as concessional, safety net and Veterans' Affairs prescriptions). For private prescriptions the quantity dispensed is assumed to be the retail pack size.
For a chronically administered drug, the DDD/1000 population/day figure indicates how many people per 1000 of the population may, in theory, have received a standard dose (as defined by the DDD) daily. 
For drugs used intermittently e.g. anti infectives, usage expressed in 
DDD/1000 population/day may similarly give a rough estimate of the average proportion of the population using these drugs every day. To estimate the number of patients treated during the year, supplementary information, such as the average duration of treatment, 
is necessary.(3)
The ATC/DDD methodology has a number of limitations. All drugs dispensed are not necessarily consumed and the DDD/1000 population/day is calculated for the total population, while drug use may be concentrated in certain age groups or a particular sex.
It is difficult to assign a DDD, and on occasions an ATC code, to some preparations that have multiple active ingredients. For some drug groups, such as the dermatological and antineoplastic drugs, highly individualised use and wide dose ranges, as well as the experimental nature of some of the therapy, make it difficult to define a daily dose. Consequently there may be a delay between the marketing of a drug and the availability of an ATC code and its associated DDD.
Generally agreed indications for use of the drug may be re-evaluated in light of experience with adverse reactions and other pharmacological effects. Drugs may have multiple indications and it may be difficult to determine what a preparation is used for. Also the DDD is based on overseas experience and may not reflect the prescribed adult dose in Australia.
Health Insurance Commission processing
In 1990 the processing of prescriptions submitted for payment of a subsidy under the 
PBS/RPBS was taken over by the Health Insurance Commission (HIC). Daily tapes containing prescription records, that do not allow the identification of an individual patient, are provided by the HIC to the Department of Health and Ageing for summarisation.
Nevertheless, significant gaps in the data result from the inability to estimate both the level of use for PBS drugs priced under the patient copayment and the level of private prescription drug use.(1)

Pharmacy Guild Survey data
Since 1989 DUSC has commissioned the Pharmacy Guild of Australia to conduct an annual survey to estimate the prescription volumes for drugs in the non-subsidised categories i.e. private prescriptions and PBS prescriptions priced under the general patient copayment. Total dispensing information is collected each month from approximately 150 pharmacies, which are members of the Pharmacy Guild.
A major pharmacy computer software supplier (Amfac) was commissioned to administer the collection of the data. Under the joint direction of DUSC and the Guild, Amfac contracted a firm of statisticians specialising in survey design and analysis to design a stratified random sample, using the Guild membership (which represents approximately 80% of pharmacies in Australia) as the population base. In 1993 the survey sample was reviewed and augmented with the assistance of the Statistical Services Section within the Department. A review of the representativeness, sample size, design and risks for the survey was carried out by the Australian Bureau of Statistics (ABS) in February 2002. It found that the relative standard error for a sample size of 150 pharmacies is 4.3%.
In the original form of the survey dispensing records from the participating pharmacies were sent to Amfac’s Canberra premises. These several hundred diskettes were summarised by drug code and category and then a single disk was forwarded to the Department. Details of the dispensing of individual participating pharmacies are not available on these data.
The Survey data was not supplied by the Guild from September 1999 to February 2001. When data collection recommenced data for this period was retrieved retrospectively using an internet connection between each participating pharmacy and Amfac. A total of 142 pharmacies participated in this data collection. Monthly data collection recommenced in February 2001. A new agreement between the software provider, the Guild and Department is being developed to ensure continuation of the Survey.
Following reinstatement of the Survey, data is now transmitted electronically from the Pharmacy Dispensary to the software provider. Data is forwarded to the Guild and thence to DUSC. The data continues to be de-indentified with respect to individual pharmacies.
The pharmacies in the survey are selected to be representative of the population of operational pharmacies on PBS dispensing volume and geographical location and similarly stratified. All pharmacies in Australia are stratified into four equal dispensing volume ranges, based on their annual average PBS dispensing from the previous year. A weighting factor is calculated for each of the volume strata by comparing the number of pharmacies in the survey with the total number of pharmacies in Australia. Volumes of non-subsidised drug use are calculated by multiplying the survey estimate by the weighting factor, which is assumed to apply equally to the subsidised and non-subsidised prescription volumes.

Combined database
A Departmental database combines the prescription estimates for the non-subsidised sector (under the general copayment and private prescriptions) from the Pharmacy Guild survey with the actual counts of those prescription categories submitted to the HIC for payment of a subsidy. Information on drugs prescribed in public hospitals and on the use of highly specialised drugs available for out-patients through public hospital pharmacies under Section 100 of the National Health Act 1953 are not included in this database.
The advantages of the expanded database can be illustrated by using an example involving utilisation data on two drugs—fluoxetine and amitriptyline. Fluoxetine has a price per prescription, as a general benefit, above the patient copayment and as a consequence, 99.17% of community use is captured on the PBS/RPBS claims database. By contrast, 79.80% of the community use of amitriptyline, which has a price per prescription below the general patient copayment, is captured on the PBS/RPBS.
Figures A and B show the time trends for dispensing of fluoxetine and amitriptyline, by the subsidised and non-subsidised components.
Figure A: Community utilisation of fluoxetine
Figure B: Community utilisation of amitriplyline

The dispensing trend for amitriptyline, a drug whose dispensed price is below the general 
copayment, shows the large component of use identified through the Pharmacy Guild survey. 
A pattern involving PBS drug utilisation that shows a higher level of usage leading up to the end of a year has been previously reported.(4) It is due to the safety net provisions introduced into the PBS in November 1986. Once the cash-based safety net level is reached, subsequent prescriptions on the scheme are either free or available at a greatly reduced copayment. The safety net period is the calendar year, and the highs and lows are due to stockpiling of medication once this safety net level is reached.
The safety net provisions were introduced into the PBS from November 1986 to ensure that patients with multiple medical conditions who genuinely need a number of medicines are not prevented financially from obtaining them.
The stockpiling of medication once the safety net level is reached has public health, waste and cost implications. Large quantities of potent medicines in the home can be a hazard for other family members, may exceed their expiry date and have the potential for patient confusion if the dosage or the need for a particular medication is subsequently reviewed by the doctor during this period.
Quantities within the PBS Schedule are designed to provide a normal course of treatment for acute conditions and a month’s treatment at usual doses for chronic conditions.
The National Health (Pharmaceutical Benefits) Regulations have been amended to increase the period for redispensing chronically used drugs (i.e. those with five or more repeats) to not less than 20 days. The exception is eye drops which tend to be used at a higher rate than other medications. The redispensing period here was amended to four rather than the previous three days.
The changes were effective from 1 November 1994.
In both cases, the pharmacist has the discretion to supply earlier than the statutory period if the circumstances warrant e.g. medicine lost or prescribed dosage requires more frequent dispensing of repeats.
Preliminary analyses of the effect of the 20 day re-supply rule suggest a smoothing out of the ‘highs and lows’ traditionally seen at the end and start of a safety net year respectively, although the total number of prescriptions dispensed has remained reasonably constant.

ADVERSE DRUG REACTIONS REPORTING IN AUSTRALIA
In Australia the Adverse Drug Reactions Advisory Committee (ADRAC) is responsible for monitoring ongoing drug safety in the post-marketing phase. The ADRAC reporting system began in the late 1960s with the computerised database dating back to November 1972. At the end of March 2004 there were almost 189,000 reports on the database and the average number of reports per month in 2003 was 960. The graph below shows the distribution and progressive increase of these reports.
In 2003, ADRAC received approximately 11,500 reports with 29% from pharmaceutical companies, 24% from general practitioners, 26% from hospitals and the remainder from other sources including including State and Territory Health Departments, members of the public, community pharmacists and specialists. The proportion of reports from pharmaceutical companies has remained steady at approximately 28–29% during 2002–2003. 
The sharp drop in reporting of adverse events by pharmaceutical companies in 2001 reflects a change in the guidelines for reporting introduced at that time that required companies to only report minor adverse reactions rather than all adverse reactions. 
The increase in the category marked ‘others’ in 2003 reflects a requirement for vaccination centres to lodge reports on adverse drug reactions introduced in 2003. ADRAC encourages practitioners to report suspected adverse reactions direct to ADRAC rather than through the manufacturer to make communication simpler.
Reports are received by the ADRAC Secretariat where they are assessed. This involves checking the report for the presence of 'minimum' details, i.e. an individual patient, an adverse reaction, at least one (suspected) drug and (preferably) an identifiable reporting health professional. The specific reaction terms are identified along with the suspected, interacting or bystander ('other') drugs. A causality rating for the reaction(s) is applied, the report is acknowledged and a decision is made as to whether further information (clinical or laboratory) is required in relation to the report. The reports are entered into the database. Selected reports are reviewed by ADRAC, with currently about 30% of reports being reviewed by this committee.
Reports are forwarded to the Uppsala Monitoring Centre in Sweden which administers the WHO Collaborating Centre for International Drug Monitoring. This global database began in 1968 as a pilot program involving 10 nations including Australia and now receives reports from over 70 nations with almost 3.08 million reports on file.
ADRAC encourages the reporting of all suspected adverse reactions to drugs and other medicinal substances, including herbal, traditional or alternative remedies. The reporting of seemingly insignificant or common adverse reactions may highlight a widespread prescribing problem. The Committee particularly requests reports of:
•	All suspected reactions to new drugs, especially Drugs of Current Interest;
•	all suspected drug interactions;
•	reactions to other drugs which are suspected of significantly affecting a patient’s management, including reactions suspected of causing:
–	death;
–	danger to life;
–	admission to hospital;
–	prolongation of hospitalisation;
–	absence from productive activity;
–	increased investigational or treatment costs; and
–	birth defects.
Reports of suspected adverse drug reactions are best made by using a prepaid reporting form ('blue card') which is available from the Adverse Drug Reactions Unit (02 62328386) or from the website: http://www.tga.gov.au/adr/bluecard.pdf. Tear out blue cards can also be found at the front of all recent editions of the 'Schedule of Pharmaceutical Benefits', and in the 'Australian Medicines Handbook'. Electronic submission of adverse drug reaction reports can be made by following the link below: http://www.tga.gov.au/problem/index.htm#medicines  

Drugs of Current Interest are newly marketed drugs that may receive widespread use and ADRAC is interested in obtaining a comprehensive safety profile. Examples for the list for 2003 are as follows:
Apomorphine (Uprima)
Aripiprazole (Abilify)
Esomeprazole (Nexium)
Fondaparinux (Arixtra)
Galantamine (Reminyl)
Gatifloxacin (Tequin)
Lercanidipine (Zanidip)
Levetiracetam (Keppra)
Meloxicam (Mobic)
Mirtazapine (Avanza, Mirtazon, Remeron)
Moxifloxacin (Avelox)
Oxcarbazepine (Trileptal)
Pioglitazone (Actos)
Pramipexol (Sifrol)
Reboxetine (Edronax)
Risedronate (Actonel)
Rivastigmine (Exelon)
Rosiglitazone (Avandia)
Sibutramine (Reductil)
Tadalafil (Cialis)
Tegaserod (Zelmac)
The Australian Adverse Drug Reactions Bulletin was published four times per year in 2001 and 2002, but from 2003 is being published six times per year. Some issues highlighted in 2003 were:
•	post-partum NSAIDs may cause hypertension;
•	rofecoxib, celecoxib and cardiovascular risk;
•	convulsions and blood dyscrasias with mirtazapine;
•	anti-epileptic drugs, pregnancy and fetal malformations;
•	maternal SSRI use and neonatal effects;
•	ACE inhibitor, diuretic and NSAID: a dangerous combination;
•	serious gastrointestinal effects with celecoxib and rofecoxib;
•	Travacalm—your reports make a difference!;
•	hyponatraemia with SSRIs;
•	fluticasone and adrenal crisis;
•	interstitial nephritis with the proton pump inhibitors;
•	minocycline and not so benign intracranial hypertension;
•	acute neuropsychiatric events with celecoxib and rofecoxib; and
•	linezolid and peripheral neuropathy.
 
THE HIGHLY SPECIALISED DRUGS PROGRAM 
Program overview
The Australian Government provides funding for certain specialised medications under the Highly Specialised Drugs Program. Highly specialised drugs (HSD) are medicines for the treatment of chronic conditions which, because of their clinical use or other special features, are restricted to supply through public and private hospitals having access to appropriate specialist facilities. To prescribe these drugs as pharmaceutical benefit items, medical practitioners are required to be affiliated with these specialist hospital units. A general practitioner or non-specialist hospital doctor may only prescribe HSDs to provide maintenance therapy under the guidance of the treating specialist.
Subsidy for drugs under this program commences after approval by the Australian Government and the States and Territories agree to the administrative arrangements. For HSDs prescribed through private hospitals, claiming and approval of authority prescriptions is administered by the Health Insurance Commission. For HSDs prescribed through public hospitals, claiming and access to the program is administered by the states/territories Health Departments.
The Australian Government provides funding for the drug to be supplied to community based patients i.e. persons who are admitted on a one-day basis, out-patients and
in-patients at discharge.
Highly Specialised Drugs Working Party
The Highly Specialised Drugs Working Party (HSDWP) was established by the Australian Health Ministers’ Advisory Council in 1991. It consists of representatives from the Health Departments of each of the states and territories, the Australian Private Hospitals Association and the Australian Government as chair. The main purpose of the HSDWP is to identify, and refer for consideration by the PBAC, those drugs which meet the selection criteria for HSDs. 

Criteria for selection of Highly Specialised Drugs
Drugs recommended for inclusion in the program must satisfy the following criteria:
(1) 	Ongoing specialised medical supervision required. 
(2) 	Treatment of longer term medical conditions not episodes of in-patient treatment or treatment of acute conditions.
(3) 	Drug highly specialised and an identifiable patient target group.
(4)	Subject to marketing approval by the TGA and specific therapeutic indications covered by the terms of the marketing letter from TGA.
(5)	High unit cost.
Highly Specialised Drugs, national usage in public hospitals in 2003
Drug	Expenditure	Packs	Patient numbers	
Abacavir sulfate	4,520,766	16,057	8,712	
Abacavir sulfate with lamivudine and zidovudine	6,642,342	7,796	4,154	
Amprenavir	404,597	1,778	577	
Apomorphne hydrochloride	765,626	27,620	296	
Azithromycin	156,241	2,304	809	
Baclofen	578,794	4,134	669	
Cidofovir	1,800	2	2	
Clarithromycin	200,076	1,470	1,339	
Clozapine	27,669,310	118,670	35,194	
Cyclosporin	26,382,482	246,456	29,176	
Darbepoetin alfa	41,755,878	65,853	29,324	
Delavirdine mesylate	108,724	400	220	
Desferrioxamine mesylate	4,151,793	66,625	2,807	
Didanoside	3,789,835	13,987	4,999	
Disodium pamidronate	8,431,723	21,913	10,235	
Dornase alfa	7,281,070	6,359	2,673	
Doxobubicin hydrochloride	119,128	184	26	
Efavirenz	4,272,716	15,809	5,665	
Epoetin	33,964,998	52,592	18,582	
Etanercept	71,924	88	16	
Filgrastim	19,742,512	11,306	6,199	
Foscarnet sodium	37,982	96	20	
Ganciclovir	2,593,975	3,623	980	
Indinavir sulfate	1,689,750	3,727	1,933	
Interferon alfa-2a	154,854	3,777	139	
Interferon alfa-2b	1,450,004	4,641	853	
Interferon gamma-1b	361,892	344	65	
Lamivudine	9,775,694	42,847	15,285	
Lamivudine and zidovudine	11,722,594	20,260	7,572	
Lanreotide acetate	275,250	367	89	
Lenograstim	397,973	407	322	
Lopinavir with ritonavir	9,482,692	29,539	5,606	
Mycophenolate mofetil	13,139,497	23,692	19,474	
Mycophenolate sodium	74,804	186	87	
Nelfinavir mesylate	2,368,243	4,802	2,604	
Nevirapine	7,087,737	26,098	9,246	
Octreotide	1,259,561	9,321	629	
Octreotide acetate	9,228,908	4,586	1,481	
Pegfilgrastim	15,854,300	8,236	6,871	
Peginterferone alfa-2b	261,568	172	62	
Ribabirin & interferon alfa-2b	10,156,869	6,509	2,988	
Ribravirin & pegInterferon alfa-2a	2,148,760	1,193	572	
Ribavirin & peginterferon alfa-2b	298,159	148	501	
Rifabutin	90,273	614	176	
Ritonavir	832,780	7,765	2,786	
Saquinavir mesylate	1,887,325	6,025	2,561	
Stavudine	6,155,505	14,859	7,717	
Tacrolimus	11,198,189	26,211	10,766	
Tenofovir disoproxil fumarate	9,566,573	18,222	6,797	
Valaciclovir hydrochloride	1,041,446	2,038	1,357	
Valganciclovir hydrochloride	527,568	235	279	
Zalcitabine	65,640	272	184	
Zidovudine	914,930	3,458	2,059	
Zoledronic acid	1,069,455	2,268	5,989	
Grand Total	324,183,086	957,942	279,724	

The program expenditure by the Australian Government has grown from less than 
$20 million in 1991–1992 to almost $376.4 million in 2003. Of this $324.2 million was expenditure in public hospitals and $52.2 million in private hospitals. 
Initially there were two drugs subsidised; however, that number has risen to 54 in 2003. Of the nine new inclusions for this financial year, three were for chronic hepatitis C, two were arthritis, one was an immuno-supressive agent, one was for acute myeloid leukemia, one was an HIV/AIDS antiretroviral agent and one was for cytomegalovirus.
Supply of pharmaceutical benefits to remote area Aboriginal Health Services (AHSs) under Section 100 of National Health Act
Special arrangements were introduced in 1999 to improve access to the PBS by clients of remote area Aboriginal health services (AHSs) under Section 100 of the National Health Act 1953.
Under these arrangements, clients of participating AHSs are able to receive PBS medicines directly from the AHS at the point of consultation, without the need for a normal prescription form, and without charge. Participating AHSs order the required PBS pharmaceuticals from pharmacies, which then transmit claims to the Health Insurance Commission for reimbursement.
The eligibility criteria for participation in the program are given below.
Eligibility criteria
1.	The health service must have a primary function of meeting the health care needs of Aboriginal and Torres Strait Islander peoples.
2.	The clinic or other health care facility operated by the AHS from which pharmaceuticals are supplied to patients must be in a remote zone as defined in the Rural, Remote and Metropolitan Areas Classification 1991 Census Edition. 
3.	The AHS must not be a party to an arrangement, such as a coordinated care trial, for which funds from the PBS have already been provided. 
4.	The AHS must employ or be in a contractual relationship with health professionals who are suitably qualified under relevant State/Territory legislation to supply all medications covered by the Section 100 arrangements and undertake that all supply of benefit items will be under the direction of such qualified persons.
5.	The clinic or other health care facility operated by the AHS from which pharmaceuticals are supplied must have storage facilities that will: 
•	prevent access by unauthorised persons;
•	maintain the quality (e.g. chemical and biological stability and sterility) of the pharmaceutical; and
•	comply with any special conditions specified by the manufacturer of the pharmaceutical.

Expenditure
The number of participating remote area AHSs has grown to 142 since the program was introduced in 1999. PBS expenditure via these arrangements for 2003 (including GST) by State/Territory was: 
State	$	
NSW	$223,561	
NT	$9,785,730	
Qld	$3,155,659	
SA	$397,129	
Tas	$35,272	
WA	$3,656,129	
Grand total	$17,253,480	

HEALTH EXPENDITURE TRENDS
Pharmaceutical(a) expenditure as % total health expenditure				
	1993	1994	1995	1996	1997	1998	1999	2000	2001	2002	2003	
Australia	10.3	10.8	11.1	11.3	11.6	11.7	12.3	13.1	13.6	13.9	14.0	
Canada	13.0	13.1	13.8	14.0	14.8	15.2	15.5	15.9	16.3	16.8	16.9	
France	17.5	17.4	17.6	17.6	18.0	18.6	19.5	20.3	20.9	20.8	20.9	
Germany	13.2	12.9	12.7	12.8	12.9	13.4	13.5	13.6	14.3	14.5	14.6	
New Zealand	14.9	15.8	14.8	14.5	14.4	n.a.	n.a.	n.a.	n.a.	n.a.	n.a.	
United Kingdom	14.8	15.1	15.3	15.6	15.8	n.a.	n.a.	n.a.	n.a.	n.a.	n.a.	
United States	8.6	8.6	8.9	9.2	9.6	10.2	11.2	11.9	12.3	12.7	12.9	

Per person expenditure on pharmaceuticals (a), $AUS (GDP purchasing power parity)	
 	1993	1994	1995	1996	1997	1998	1999	2000	2001	2002	2003	
Australia	214	236	256	278	300	318	338	419	459	506	n.a.	
Canada	343	348	377	381	419	456	484	533	604	639	684	
France	428	430	450	454	476	512	559	642	720	771	818	
Germany	335	355	372	390	415	444	459	500	539	565	589	
New Zealand	217	245	236	238	254	n.a.	n.a.	n.a.	n.a.	n.a.	n.a.	
United Kingdom	242	257	262	293	312	n.a.	n.a.	n.a.	n.a.	n.a.	n.a.	
United States	387	402	418	455	494	550	628	714	811	898	983	

Total expenditure on health as % GDP
 	1993	1994	1995	1996	1997	1998	1999	2000	2001	2002	2003	
Australia	8.3	8.3	8.4	8.5	8.6	8.7	8.9	9.2	9.3	9.5	9.3	
Canada	9.9	9.5	9.2	9.0	8.9	9.2	9.0	8.9	9.4	9.6	9.9	
France	9.4	9.4	9.5	9.5	9.4	9.3	9.3	9.3	9.4	9.7	10.1	
Germany	9.9	10.2	10.6	10.9	10.7	10.6	10.6	10.6	10.8	10.9	11.1	
New Zealand	7.2	7.2	7.2	7.2	7.4	7.8	7.7	7.8	7.9	8.2	8.1	
United Kingdom	6.9	7.0	7.0	7.0	6.8	6.9	7.2	7.3	7.5	7.7	7.7	
United States	13.2	13.1	13.3	13.2	13.0	13.0	13.0	13.1	13.9	14.6	15.0	

											(a) See note below for definition: 'Pharmaceuticals' defined.							
n.a. not available (data not provided to the OECD by these countries for these years)
Sources: AIHW health expenditure database, OECD Health Data 2005			
‘Pharmaceuticals’ defined
For countries other than Australia, the OECD definition of pharmaceuticals has been used, as described in its System of Health Accounts (SHA). The OECD defines pharmaceuticals as ‘pharmaceuticals and other medical non-durables dispensed to out-patients’, which comprises prescription medicines, over-the-counter medicines and other medical non-durables. 
Broadly speaking, these include medicinal preparations, branded and generic medicines, drugs, patent medicines, serums and vaccines, vitamins and minerals, and oral contraceptives and a wide range of medical non-durable goods, which are either single use items, for example bandaids and condoms, or have limited re-usage, for example, bandages. 
Prescribed medicines are medicines exclusively sold to customers with a medical voucher, irrespective of whether it is covered by public or private funding and include branded and generic products. In the SHA, this includes the full price with a breakdown for cost-sharing.
Over-the-counter medicines (OTC medicines) are classified as private households’ pharmaceutical expenditure of non-prescription medicines.
Other medical non-durables comprise items such as bandages, elastic stockings, 
incontinence articles, condoms and other mechanical contraceptive devices.
In terms of Australian pharmaceutical expenditure, the Australian Institute of Health and Welfare (AIHW) splits expenditure into two categories, ‘benefit paid pharmaceuticals’ and ‘all other pharmaceuticals’. 
‘Benefit paid pharmaceuticals’ are pharmaceuticals in the Pharmaceutical Benefits Scheme (PBS) and the Repatriation Pharmaceutical Benefits Scheme (RPBS) for which the Australian Government paid a benefit. 
‘All other pharmaceuticals’ are pharmaceuticals for which no PBS or RPBS benefit was paid and includes the following:
•	pharmaceuticals listed in the PBS or RPBS, where the total costs are equal to, or less than, the statutory patient contribution for the class of patient concerned (under co–payment drugs);
•	medicines dispensed through private prescriptions for items not listed in the PBS or RPBS; and
•	over–the–counter medicines such as aspirin, cough and cold medicines, vitamins and minerals, some herbal and other complementary medicines and medical 
non-durables goods, as listed above.

DRUG UTILISATION TRENDS
Listed below in Table A are the prescription counts for 2001, 2002 and 2003 by ATC anatomical main group. The data from the two sources are enumerated separately 
i.e. subsidised prescriptions (PBS/RPBS) and the estimate of non-subsidised prescriptions (survey). 
Table A Prescription numbers by ATC groups
(i) Subsidised prescriptions (PBS/RPBS) 
ATC group	2001	2002	2003	
(A)	Alimentary tract	19,377,530	21,520,117	22,740,681	
(B)	Blood and blood forming	4,407,802	5,279,172	6,055,450	
(C)	Cardiovascular system	49,300,928	52,756,536	55,636,426	
(D)	Dermatologicals	3,377,463	3,307,135	3,197,626	
(G)	Genitourinary system	6,443,505	5,783,534	4,757,566	
(H)	Hormonal preparations	2,453,513	2,552,152	2,598,634	
(J)	Antiinfectives	13,190,129	12,833,584	12,630,126	
(L)	Antineoplastic	1,007,024	1,106,179	1,200,722	
(M)	Musculoskeletal	10,490,476	12,346,379	13,069,777	
(N)	Nervous system	33,251,028	34,236,817	35,150,181	
(P)	Antiparasitic products	1,141,511	1,150,432	1,129,459	
(R)	Respiratory system	11,382,688	11,154,201	10,847,119	
(S)	Sensory organs	7,615,186	7,891,125	8,034,352	
(V)	Various	693,188	721,603	691,238	
Other	348,730	333,107	318,233	
Total	164,480,701	172,972,073	178,057,590	

(ii) Estimated non-subsidised prescriptions (Survey)
ATC group	2001	2002	2003	
(A) Alimentary tract	3,221,742	3,068,909	2,850,999	
(B) Blood and blood forming	586,114	566,430	571,578	
(C) Cardiovascular system	3,420,028	3,362,802	3,550,849	
(D) Dermatologicals	2,442,141	2,252,786	2,174,243	
(G) Genitourinary system	7,298,700	6,586,493	6,230,972	
(H) Hormonal preparations	949,593	905,409	918,520	
(J) Antiinfectives	10,990,671	10,012,415	9,184,888	
(L) Antineoplastic	97,130	79,600	81,618	
(M) Musculoskeletal	2,057,786	1,946,815	2,038,056	
(N) Nervous system	7,648,118	7,463,102	7,214,871	
(P) Antiparasitic products	465,874	405,574	372,692	
(R) Respiratory system	3,187,972	3,465,675	3,315,126	
(S) Sensory organs	1,976,125	1,757,452	1,700,054	
(V) Various	26,611	64,107	18,639	
Other	1,631,437	1,692,031	1,778,849	
Total	46,000,042	43,629,600	42,001,954	

The estimated changes 1994 to 2003 in the number of prescriptions dispensed under the PBS (concessional and general), RPBS, under copayment and private categories are presented in Figure C. 
Figure C: Number of prescriptions by type of service 

A number of tables and figures describing the most commonly used drugs in 2003 are included below. Table B shows the top 10 drugs dispensed in the Australian community by DDDs/1000 population/day, which adjusts for the quantity dispensed per prescription. This DDD/1000/day information is presented both as a total community use and split between the subsidised (PBS/RPBS) and non-subsidised (Guild survey) components. 
Table B: Top 10 drugs by defined daily dose/thousand population/day, 2003  
Drug	PBS/RPBS	Guild Survey	Total	
			community use	
1	Atorvastatin	72.100	0.115	72.215	
2	Simvastatin	46.946	0.044	46.990	
3	Diltiazem hydrochloride	38.170	0.196	38.366	
4	Rampril	29.038	0.559	29.597	
5	Salbutamol	20.009	7.584	27.593	
6	Omeprazole	21.667	0.054	21.721	
7	Frusemide	19.210	1.170	20.380	
8	Irbesartan with hydrochlorothiazide	19.243	0.036	19.279	
9	Irbesartan	18.846	0.171	19.017	
10	Aspirin	16.655	1.087	17.742	

Changes from 2002:
	UP: simvastatin (3  2), ramipril (5  4)
	DOWN: diltiazem hydrochloride (2  3), salbutamol (4  5), irbestartan (8  9) 
	IN: irbesartan with hydrochlorothiazide, aspirin
	OUT: celecoxib (9  13), amlodipine besylate (10  12)

Table C shows the top 10 drugs dispensed in the Australian community ranked by prescription count for 2003. Table D ranks the top 10 drugs by cost to Government 
i.e. subsidised prescriptions only for 2003.
Table C: Top 10 drugs by prescription counts—2003

Drug	PBS/RPBS	Guild Survey	Total	
			community use	
1	Atorvastatin	6,600,486	12,126	6,612,612	
2	Simvastatin	5,708,918	5,554	5,714,472	
3	Paracetamol	4,632,689	91,443	4,724,132	
4	Omeprazole	4,546,226	11,579	4,557,805	
5	Amoxycillin	2,332,539	2,061,114	4,393,653	
6	Salbutamol	3,266,510	1,095,182	4,361,692	
7	Atenolol	3,053,699	792,539	3,846,238	
8	Codeine with paracetamol	2,700,004	1,089,944	3,789,948	
9	Celecoxib	3,373,017	31,905	3,404,922	
10	Irbesartan	3,212,053	72,731	3,284,784	

Changes from 2002:
	UP: amoxycillin (6  5), atenolol (9  7))
	DOWN: salbutamol (5  6), codeine with paracetamol (7  8), celecoxib (8  9)
	IN: ibesartan
	OUT: temazipam (10  14)
Table D: Top 10 drugs by cost to Government—2003
Drug	PBS/RPBS	PBS/RPBS	Cost to	
 	DDD/1000/day	scripts	government ($A)	
1	Atorvastatin	72.1	6,600,486	364,401,893	
2	Simvastatin	46.946	5,708,918	341,921,246	
3	Omeprazole	21.667	4,546,226	200,414,114	
4	Salmeterol and fluticasone	.	2,582,663	159,025,432	
5	Olanzapine	2.879	706,957	148,197,152	
6	Pravastatin	13.299	2,046,610	120,218,644	
7	Clopidogrel	5.671	1,430,564	113,929,506	
8	Rofecoxib	10.763	3,032,135	94,804,356	
9	Alendronic acid	7.43	1,801,286	93,266,001	
10	Esomeprazole	7.351	1,833,287	92,174,906	

Changes from 2002:
	UP: clopidogrel (10  7)
	DOWN: celecoxib (7  11)
	IN: alendronic acid (alendronate), esomeprazole
	OUT: pantoprazole (9  12)
Figure D presents the top 10 subsidised drugs dispensed in 2003.
Figure D: Top 10 subsidised drugs dispensed in 2003
Figure E presents the top 10 non-subsidised drugs for 2003.
Figure E: Top 10 non-subsidised drugs dispensed in 2003

TABLES IN THE AUSTRALIAN STATISTICS ON MEDICINES
The data are presented in two major tables. Table 1 is an estimate of the 2003 community (i.e. subsidised and non-subsidised) prescription numbers, together with the costs for PBS listed drugs, which include an estimate of the cost of under copayment PBS prescriptions. Cost information on the dispensing of private prescriptions is not available. The defined daily doses (DDDs), where available, are also included for the drugs covered in the report.
Table 2 includes community prescription drug use, in DDDs/1000 population/day, for the years 2001 to 2003.
References
(1)	Edmonds DJ, Dumbrell DM, Primrose JG, McManus P, Birkett DJ, Demirian V. Development of an Australian drug utilisation database: a report from the Drug Utilisation Subcommittee of the Pharmaceutical Benefits Advisory Committee PharmacoEconomics 1993; 3(6): 427 432.
(2)	Hurley SF, McNeil JJ. Drug coding systems: why so many?  Med J Aust 1989; 
151: 308.
(3)	Nordic Council on Medicines. Nordic Statistics on Medicines 1987–1989. 
NLN publication number 3, Uppsala, Sweden, 1990.
(4)	McManus P. Drug utilisation (letter) Med J Aust 1993; 158: 724.

CAVEATS
It needs to be borne in mind that these utilisation data do not include over-the-counter purchase (except for S3 Recordable), public hospital drug usage or the supply of highly specialised drugs to out-patients through public hospitals under Section 100 of the National Health Act 1953. Some extemporaneously prepared items may also not be included.           
Comments on classifications, omissions or errata appearing in this edition of the Australian Statistics on Medicines may be sent to: 
	Maxine Robinson 
	Secretary 
	Drug Utilization Sub-Commitee (DUSC) 
	Department of Health and Aged Care 
	GPO Box 9848 
	CANBERRA ACT 2601
	e-mail: maxine.robinson@health.gov.au	

Actu    	Actuated
Adhes     	Adhesive
Admin     	Administration
Aero      	Aerosol
Amp(s)    	Ampoule(s)
Applic     	Applicator
Aqu       	Aqueous
Breth      	Breath
Calc      	Calcium
Cap(s)     	Capsule(s)
Cart      	Cartridge
CD       	Controlled delivery  
Chew      	Chewable
Clean      	Cleansing
Coat      	Coated
Co       	Compound
Conc      	Concentrated
Cont      	Contained
CR       	Controlled release
Crm       	Cream
Crush      	Crushable
D        	Dose
Dev       	Device
Diag      	Diagnostic
Dil       	Diluted
Disp      	Dispersable
Dres      	Dressing
Drp       	Drops
Ds       	Doses
Dust      	Dusting
Efferv     	Effervescent
Elx       	Elixir
Enter      	Enteric
Emulsif     	Emulsifying
Equiv      	Equivalent
Extend     	Extended
Ferr      	Ferrous
Gran      	Granules
Inf       	Infusion
Inhal      	Inhalation
Inj(s)     	Injection(s)
Inrt      	Inert
Ins       	Insert
Intracav	Intracavernosal
Intranas    	Intranasal
Insuff     	Insufflator
Irrig      	Irrigation
Jel       	Jelly
Linct      	Linctus
Lin       	Liniment
Liq       	Liquid
Loz       	Lozenge
Ltn       	Lotion
Metronid	Metronidazole
Mixt      	Mixture
Nas       	Nasal
Nebu      	Nebuliser
Not<      	Not less than
Oint      	Ointment
Ophth    	Ophthalmic
Paed      	Paediatric
Pdr       	Powder
Pell(s)     	Pellet(s)
Pess      	Pessary
Phos      	Phosphorus
Pot       	Potassium
Prep      	Preparation
Press      	Pressurised
Prot      	Protective
Pst       	Paste
Reag      	Reagent
Rel       	Release
Requ      	Required
Sach(s)  	Sachet(s)
SF	Sugar free
Sng       	Single
Sod       	Sodium
Sol       	Soluble
Soln      	Solution
Solv      	Solvent
Spr       	Spray
Ster      	Sterile
Sulph      	Sulphate
Suppl      	Supplement
Suppos     	Suppository
Supres     	Suppression
Susp      	Suspension
Sust      	Sustained
Syrp      	Syrup
Syrng      	Syringe
Tab(s)     	Tablet(s)
Td       	Transdermal
Tinct      	Tincture
Top       	Topical
Unt(s)     	Unit(s)
wps       	Wipes
Weights and Measures
cm       	centimetre(s)
E        	unit(s)
g        	gram(s)
kg       	kilogram(s)
iu       	international unit
L        	litre(s)
m        	metre(s)

ME	million units
mm       	millimetre(s)
mg       	milligram(s)
mL       	millilitre(s)
mmol	millimole
TE       	thousand units
ug       	microgram(s)
ATC & DDD CHANGES 2003
The tables are structured using the 2003 ATC index, but use the DDD relevant to the data year contained in the book, in this edition the calendar year 2003. A number of changes apply from the previous edition of the ASM and include:
(1) Alterations in ATC classification in 2003
Drug/drug group 	Previous ATC code	New ATC code	
Chondroitin sulfate	M09AX02	M01AX25	
Levocetirizine	R06AE08	R06AE09	

New levels established in 2003
H05A	Parathyroid hormones and analogues
H05AA	Parathyroid hormones and analogues
J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
(2) Alterations in DDDs for 2003	
		Previous DDD	New DDD	
B03BB01	Folic acid	0.3* mg O	0.4 mg O	
		10** mg O	deleted	
R01AD05	Budesonide	0.3 mg N	0.2 mg N	

* prophylactic dose
** therapeutic dose
Parenteral therapeutic dose unchanged 
(3) New DDDs assigned in 2003
A08AA10	Sibutramide	10 mg O	
A16AB03	Agalsidase alfa	1 mg P	
A16AB04	Agalsidase beta 	5 mg P	
G01AD03	Ascorbic acid	0.25 g V	
G03CA03	Estradiol	0.3 mg N	
J01XX08	Linezolid	1.2 g O,P	
J02AX04	Caspofungin	50 mg P	
J05AB14	Valganciclovir	0.9 g O	
J05AE05	Amprenavir	2.4 g O	
J05AE06	Lopinavir	0.8g O	
L04AA10	Sirolimus	6 mg O	
M03BX01	Baclofen	0.55 mg P	
N05AH03	Olanzapine	10 mg P	
N05AL05	Amisulpride	0.4 g O	
N06AB10	Escitalopram	10 mg O	
N07BB04	Naltrexone	50 mg O	
S01EX04	Unoprostone	0.2 ml	

(4) Allocation of ATC codes and DDDs to new products
ATC codes assigned to drugs marketed or listed on the PBS since the 2001–2002 
edition include:
2003		
Famotidine, combinations	A02BA53	
Tenecteplase	B01AD11	
Protein C	B01AD12	
Fondaparinux	B01AX05	
Ferric sodium gluconate complex	B03AC07	
Other hypertensives	C02KX	
Bosentan	C02KX01	
Simvastatin, combination packages	C10AA51	
Ezetimibe	C10AX09	
Calcipotriol, combinations	D05AX52	
Teriparatide	H05AA02	
Voriconazole	J02AC03	
Valganciclovir	J05AB14	
Tenofovir disoproxil	J05AF07	
MeningococcusC, purified polysaccharides antigen conjugated	J07AH07	
Diphteria-haemophilus influenzae B-pertussis—poliomyelitis—tetanus—hepatitis B	J07CA09	
Other plant alkaloids and natural products	L01CX	
Gefitinib	L01XX31	
Pegfilgrastim	L03AA13	
Valdecoxib	M01AH03	
Parecoxib	M01AH04	
Escitalopram	N06AB10	
Povidone-iodine	S01AX18	

Full details on current ATC coding and defined daily doses (DDDs) can be obtained from the DUSC Secretary, Department of Health and Aged Care, GPO Box 9848, Canberra ACT 2601 or direct from the coordinating body, the WHO Collaborating Centre for Drug Statistics Methodology, P.O. Box 100, Veitvet 0518 Oslo Norway.