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Australian Statistics on Medicines 2011

Page last updated: 28 January 2014

Australian Statistics on Medicines 2011 (PDF 5.2 MB)
Table 1 (Excel 357 KB)
Table 2 (Excel 244 KB)

Acknowledgments

Prepared by Vanna Mabbott, Maxine Robinson and Alicia Segrave of the Pharmaceutical Benefits Division.

We would like to thank the following people for their help in the access and provision of data and information used in this report:

  • The World Health Organization Collaborating Centre for Drug Statistics Methodology.
  • Kavita Verma, Pharmaceutical Access, Department of Health.
  • Christopher Parker, Pharmaceutical Access, Department of Health.
  • Katherine Gray, Advisory Committee on the Safety of Medicines, Therapeutic Goods Administration.
  • Rebecca Bennetts, Australian Institute of Health and Welfare.

Australian Statistics on Medicine 2011

Print ISBN: 978-1-74186-083-2

Online ISBN: 978-1-74186-084-9

Publications approval number: 10534

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© Commonwealth of Australia 2013

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© Commonwealth of Australia 2013

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FOREWORD

It is my great pleasure to introduce the 17th Edition of the Australian Statistics on Medicines. This publication provides an extensive and extremely valuable set of statistics on the use of prescription medicines in Australia from 1991 to 2011. Data in this edition were obtained from the Pharmaceutical Benefits Scheme, the Repatriation Pharmaceutical Benefits Scheme and an ongoing survey of a representative sample of community pharmacies.

Knowledge about the usage, cost and trends over time in prescription medications is clearly relevant for all four aspects of the National Medicines Policy: access to medicines; quality, safety and efficacy of medicines, quality use of medicines; and a responsible and viable medicines industry. These data are routinely scrutinized by the Drug Utilisation Sub-Committee (DUSC) which has provided advice to the Pharmaceutical Benefits Advisory Committee and other stakeholders within the National Medicines Policy Framework about the use (predicted and actual) of medicines in Australia since 1988. This advice is critical with the number, usage, cost and complexity of prescription medicines increasing with an ageing population and ongoing development of new and innovative medicines. Data from the Australian Statistics on Medicines and advice from DUSC provide an integral contribution to the monitoring and quality assurance of the Pharmaceutical Benefits Scheme, prescribers and the medicines industry.

This edition of the Australian Statistics on Medicines was prepared by staff of the Pharmaceutical Benefits Division. I acknowledge their skill and expertise and thank them for their extraordinary commitment and hard work. The Australian Statistics on Medicines has a critical role in our health care system and provides information that ultimately improves the health of Australians.

Geoff McColl
FRACP PhD

Chair, Drug Utilisation Sub-Committee

Contents

 

INTRODUCTION

The data contained in the 2011 Australian Statistics on Medicines are drawn from two sources. The first is the Department of Human Services records of prescriptions submitted for payment of a subsidy under the Pharmaceutical Benefits Scheme (PBS) and Repatriation Pharmaceutical Benefits Scheme (RPBS). The second is a 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 not available in this report. The usage of subsidised PBS/RPBS prescription medicines to out-patients and discharged patients in five states of Australia and one territory are 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 World Health Organization Collaborating Centre (WHOCC) 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 2011 community (i.e. subsidised and non-subsidised) prescription numbers. These figures are presented 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 for the period of this report. Collection of under general co-payment PBS volume data commenced on 1 April 2012, and will inform future reports thereafter. Table 2 includes community prescription drug use, in DDDs/1000 population/day, for the years 2009, 2010 and 2011. Table 2 reports the DDDs for each drug, reporting the use in monocomponent (‘plain’) and in fixed dose combination formulations.

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INFORMATION ON THE AUSTRALIAN STATISTICS ON MEDICINES

Overview

The development, monitoring and promotion of rational and cost-effective use of medications in society are dependent on accurate information on patterns of drug prescription and use. Where use is considered to be inappropriate, drug utilisation data can monitor the impact of educational or regulatory interventions, and can guide the interpretation of pharmacoeconomic analysis1.

In Australia, community prescriptions (i.e. non-public hospital) are dispensed either as private prescriptions, funded by the patient or private health insurer, or under one of two Government 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. Since 2002 prescriptions for an increasing number of public hospital outpatients and many medicinal products supplied at discharge for in-patients have been included in the dataset. In 2011, the RPBS was 6% of the size of the PBS and a large majority, approximately 93%, of RPBS prescriptions involved PBS listed drugs.

In Australia, a new medicinal drug must gain approval for supply in accordance 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. From 1963 to 2009 this advice was provided by the Australian Drug Evaluation Committee (ADEC). ADEC was replaced in January 2010 with the Advisory Committee on Prescription Medicines (ACPM).

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. The subsidised cost, particularly for newer drugs, reduces consumers’ out of pocket expenses therefore many companies seek to have the drug listed on the scheme to facilitate viable marketing.

The Pharmaceutical Benefits Advisory Committee (PBAC) makes recommendations to the Australian Government about which drugs should be listed on the PBS. Pre-market evaluation addresses the issues of quality, safety and efficacy, whereas the PBAC considers effectiveness and cost-effectiveness of the product relative to alternatives, as well as the overall cost to the Government. Once the PBAC has recommended a drug for listing on the PBS, the Pharmaceutical Benefits Pricing Authority (PBPA) negotiates the price with the sponsor 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 will be listed on the PBS.

Under the PBS, patient contributions towards medication costs at pharmacies are capped. In 2011, general patients paid the cost of a prescription up to a maximum of $34.20. Pensioner and concession patients paid $5.60 per prescription.

In addition, there is a Safety Net Scheme to protect people with high medication needs. In 2011, once general patients and/or their immediate family incurred $1,317.20 of PBS expenditure (indexed), PBS/RPBS prescriptions for the remainder of the calendar year cost only $5.60 per prescription. Once pensioners and other concession card holders reached the concession safety net threshold of $336 expenditure (indexed), they received all remaining prescriptions in 2011 free of charge.

It is important to note that patients may be required to pay a surcharge if a 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 co-payment rises, the dispensed price of many cheaper medical products fall under this level. In such cases the patient pays the full price and no claim for payment was transmitted under the PBS for the period of this report. In 2011, under co-payment general prescriptions represented around 17.9% of all community prescriptions. 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. Private prescriptions represented 7.2% of community prescriptions in 2011.

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Pharmaceutical Benefits Advisory Committee

The Pharmaceutical Benefits Advisory Committee (PBAC) is an independent statutory body established on 12 May 1954, under section 100A of the National Health Act 1953. The role of PBAC is 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 recommended by the PBAC.

The PBAC is required by the Act to consider the effectiveness and cost of a proposed benefit compared to alternative therapies. In making its recommendations, the PBAC, on the basis of expected 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 PBAC provides advice to the PBPA regarding comparison with alternatives or their cost effectiveness.

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Drug Utilisation Sub-Committee

In 1988, the PBAC convened the Drug Utilisation 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, analysis and interpretation of comprehensive data on utilisation of medicines in Australia.
  • To advise PBAC on changes in patterns of utilisation of medicines as a consequence of changes in their availability or subsidy restrictions and to review the utilisation of medicines, including but not restricted to expenditure impacts within the Pharmaceutical Benefits Scheme (PBS).
  • To advise stakeholders within the National Medicines Policy framework on the interpretation of patterns of utilisation of medicines, including by placing the results of the data in the context of the limitations of the data.
  • To identify potential problems and benefits related to patterns of utilisation of medicines.
  • To evaluate policy and other interventions related to the use of medicines.
  • To facilitate and promote the dissemination of information on utilisation of medicines.
  • To conduct international comparisons of utilisation of medicines by interaction with appropriate
    international bodies.

 

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National Medicines Policy

The National Medicines Policy (NMP) is a broad framework that aims to improve health outcomes for all Australian’s through access to and appropriate use of medicines.

The overall aim of the NMP is to meet medication and related service needs, so that both optimal health outcomes and economic objectives are achieved. In this context “medicines” means prescription, non-prescription and complementary healthcare products.

The NMP has four central objectives:

  • timely access to the medicines that Australian’s need, at a cost individuals and the community can afford;
  • medicines meeting appropriate standards of quality, safety and efficacy;
  • quality use of medicines;
  • and maintaining a responsible and viable medicines industry.

Further information is available on the National Medicines Policy web page.

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Drug Classification

The DUSC and the Department of Health 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 1982, the WHO Collaborating Centre for Drug Statistics Methodology (WHOCC), located in Norway, was established as a central body responsible for coordinating ATC use.

The ATC code itself is a seven digit alphanumeric code, structured in five 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 subgroup and pharmacological subgroup, respectively, with a fourth level being either a chemical or therapeutic subgroup. The fifth level is the actual chemical substance.

The five levels thus are:

  1. anatomical main group
  2. pharmacological/therapeutic subgroup
  3. chemical/pharmacological or therapeutic subgroup
  4. chemical/pharmacological or therapeutic subgroup
  5. chemical substance (generic drug name)

For example, risperidone has the following code:N 05 A X 08.

Risperidone codes
N denotes Nervous system
05 Psycholeptics
A Antipsychotics
X Other antipsychotics
08 Risperidone

ATC system main groups:

The 14 anatomical main groups of the ATC code are:

Main groups of the ATC code
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, excluding sex hormones and insulins
J. Anti-infectives for systemic use
L. Antineoplastic and immunomodulating agents
M. Musculo-skeletal system
N. Nervous system
P. Antiparasitic products, insecticides and repellents
R. Respiratory system
S. Sensory organs
V. Various

Although the ATC code extends to the generic drug level, it does not identify dosage forms, pack sizes, strengths or brand names.

The WHOCC, together with the Nordic Council on Medicines, undertakes regular revisions of the ATC system. 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. Changes implemented in 2012 are included in the Anatomical Therapeutic Chemical Index (ATC) & Defined Daily Dose (DDD) additions and alterations section in this publication.

 

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Measurement Unit

The international unit of drug utilisation adopted by the DUSC to accompany this coding system is the defined daily doses, per thousand of the population, per day (DDDs/1000/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, when used for its main indication by adults3.

Use of DDDs 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. The DDD, however, is only a technical unit of use and does not necessarily reflect the recommended or average prescribed dose in Australia.

The DDDs/1000/day figure is calculated from prescription data in the following way:

DDDs/1000/day figure calculation

N x M x Q x 1000

DDD x P x D

Where:

DDDs/1000/day figure codes
N is the number of prescriptions dispensed in the year
M is the drug mass in each unit (tablet, capsule, injection, pack etc.) (e.g. milligrams or grams, expressed in the same unit as DDD)
Q is the average dispensed quantity (ie. number of units)per prescription

P

 is the midyear Australian population for the year of data collection (see Australian Bureau of Statistics website for population figures used in this edition.
D is the number of days in the year.

The DDDs/1000/day 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 the Pharmacy Guild survey. The data from the survey does not include information on the quantity supplied per prescription, therefore the mass amount for nonsubsidised 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 Department of Human Services data. For prescriptions that are priced under the general co-payment, quantity is assumed to be the average quantity of the subsidised prescriptions for that drug (i.e. as concession, safety net and Veterans’ Affairs (Repatriation) prescriptions). For private prescriptions, the quantity dispensed is assumed to be the retail pack size.

For a chronically administered drug, the DDDs/1000/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, for example antiinfectives, usage expressed in DDDs/1000 /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 necessary3.

The ATC/DDD methodology has a number of limitations. All drugs dispensed are not necessarily consumed and the DDDs/1000/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 a 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 a preparation’s use. Also, the DDD is based on overseas experience and may not reflect the prescribed adult dose in Australia.

As more medicinal products are listed on the PBS in formulations of two or more combinations the DUSC has considered that it is important to record the contribution, in terms of DDDs, of each constituent where appropriate. Therefore additional information on the contribution of the constituents of combination pharmaceutical items in addition to single component items will be reported in table 2.

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Department of Human Services 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, now the Department of Human Services. Daily data transmissions, containing prescription records that do not allow the identification of an individual patient, are provided by the Department of Human Services to the Department of Health for summarisation.

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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 nonsubsidised categories i.e. private prescriptions and PBS prescriptions priced under the general patient co-payment. Total dispensing information is collected each month from pharmacies that are members of the Pharmacy Guild. The sample increased in 2007 from 150 to 370.

Amfac, a major pharmacy computer software supplier, was commissioned to administer the collection of the data in 1988. 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 a small relative standard error, for the sample size of 150 pharmacies, of 4.3%.

In the original form of the survey, dispensing records from the participating pharmacies were sent to Amfac’s Canberra premises. Several hundred diskettes were summarised by drug code and category. A single disk was then 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 monthly data collection recommenced in February 2001, retrospective data was retrieved using an internet connection between each participating pharmacy and a software provider. A total of 142 pharmacies participated in this data collection.

Following reinstatement of the Survey, data is now transmitted electronically from the participating pharmacy dispensaries to the software providers. Data is forwarded to the Guild and then to DUSC. The data continues to be de-identified with respect to individual pharmacies and individual patient prescriptions.

The pharmacies in the survey are selected to be representative of the population of operational pharmacies with regard to PBS dispensing volume and geographical location, and are similarly stratified. In order to compare and then extrapolate the survey quantities to estimates of use in Australia, the subsidised PBS prescription data supplied by all pharmacies in Australia are stratified into the same four equal dispensing volume ranges based on their annual average PBS dispensing from the previous year. A weighting factor is calculated for each PBS and Amfac item code by comparing the number of pharmacies and PBS prescriptions in the survey with the total number of pharmacies and PBS prescriptions in Australia for each stratum. 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 nonsubsidised prescription volumes.

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Combined database

A Departmental database combines the prescription estimates for the non-subsidised sector, under general co-payment and private prescriptions, based on the survey with the actual counts of those prescription categories submitted to the Department of Human Services for payment of a PBS/RPBS subsidy by the Government. A number of other Government subsidised programs and PBS programs subsidised through alternative supply arrangements are not included in the DUSC database. This includes the use of highly specialised drugs available for outpatients through public hospital pharmacies under Section 100 Highly Specialised Drugs Program of the National Health Act 1953, supply of drugs to remote area Aboriginal Health Services, Opioid Dependence Scheme, IVF/ GIFT Treatment and Botulinum Toxin Program. Subsidised programs operated by State Health Departments, including supply of drugs to public hospital in-patients, and the Herceptin Program for metastatic breast cancer are also excluded from the DUSC database. The combined dataset does contain information on highly specialised drugs and in-patient drugs provided through private hospitals as this information is collected by the Department of Human Services. Following a range of pharmaceutical reforms a greater number of s100 Highly Specialised Drugs, and outpatient or discharge drugs supplied through public hospital will be included in the DUSC database in the future.

The advantages of the expanded database can be illustrated by using an example involving the drug sotalol hydrochloride. Previously, sotalol hydrochloridehad a price per prescription, as a general benefit, above the patient co-payment and, as a consequence, a majority of community use was captured on the PBS/RPBS claims database. In 2008, a reduction in drug price and a small increase in the general patient co-payment in line with the Consumer Price Index (CPI) contributed to the price of sotalol hydrochloride falling below the general patient co-payment. Changes in the capturing of sotalol hydrochloride data from the Department of Human Services claims database to the Pharmacy Guild Survey database can be seen in figure A. The combined database therefore enables the continuation of utilisation estimates for drugs not subsidised through the PBS/RPBS and provides a more comprehensive outlook on drug use within Australia.

Figure A shows the time trends for dispensing of sotalol hydrochloride, by the subsidised and non-subsidised components.

Figure A: Community utilisation of sotalol hydrochloride

Figure A : Community utilisation of Sotalol Hydrochloride

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.

A pattern involving PBS drug utilisation that shows a higher level of usage leading up to the end of a year has been previously reported4. This peak is due to the safety net provisions introduced into the PBS in November 1986. These provisions were introduced to financially support patients with multiple medical conditions who genuinely need a number of medicines. Once the out-of-pocket threshold safety net level is reached, prescriptions on the scheme are either free, or available at a greatly reduced co-payment amount. The safety net period is the calendar year, and the highs and lows are due to stockpiling of medication once the safety net level is reached.

The stockpiling of medication 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 has the potential for patient confusion if the dosage or the need for a particular medication is subsequently reviewed by the doctor during this period.

On 1 November 1994 the National Health (Pharmaceutical Benefits) Regulations were amended to increase the period for redispensing chronically used drugs (i.e. those with 5 or more repeats) to a period of no less than 20 days. Exceptions are determined by the PBAC and include 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 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.

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ADVERSE EVENT REPORTING IN AUSTRALIA IN 2011

The Therapeutic Goods Administration (TGA) is responsible for regulating medicines in Australia, including monitoring the ongoing safety of medicines once they have been included on the Australian Register of Therapeutic Goods (ARTG).

The TGA’s reporting system for adverse events began in the late 1960’s with the computerised database dating back to November 1972. At the end of 2011 there were approximately 247,000 reports of suspected adverse events in the database.

Figure B: Origin of adverse event reports received by the TGA (2006-2011)

Figure B : Origin of adverse event reports received by the TGA.

Note: A review of the quality control process had an impact on the searchable part of the Adverse Drug Reaction Database, causing a change in the number of events from data published in the Adverse Drug Reaction Reporting in Australia in 2010.

In 2011 the TGA received approximately 14,400 reports with 52% from pharmaceutical companies, 12% from hospitals, 7% from General Practitioners (GPs), 18% from State and Territory Health Departments and 3% from consumers. The sources for other reports (8%) include community pharmacists and specialists (Figure B). On average, in 2011, the TGA received 1,200 reports per month. Health professionals are encouraged to report suspected adverse events directly to the TGA rather than through the sponsor or manufacturer to simplify communication.

The spike in the number of adverse events reported by companies in 2011 is attributed to a number of factors, including a greater number of drugs on the Australian Register of Therapeutic Goods (ARTG); and the possibility that GPs are reporting adverse events via sponsors, which would also account for the slight drop in the reporting rates for GPs. The increases observed in 2009 and 2010, particularly from State and Territory Health Departments and companies, is largely due to reports of adverse events following vaccination with the pandemic (H1N1) influenza vaccine in 2009 and the seasonal trivalent influenza vaccines in 2010.

Processing and use of adverse event reports

Reports are assessed by the Office of Product Review (OPR) within the TGA. This involves checking the report for the presence of ‘minimum’ details, i.e. an individual patient, an adverse event, at least one (suspected) drug, and, preferably, an identifiable reporting health professional. The specific reaction terms are identified along with the suspected, interacting or ‘other’ drugs and these are entered into the database.

The TGA applies a causality rating for the reaction(s) and in some cases requests further clinical or laboratory information from the reporter to allow causality to be assessed. Medical officers review serious reports and staff in OPR regularly analyse reporting data to identify potential safety signals.

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 80 nations with over 5 million reports in the database.

Reporting adverse events

The TGA encourages the reporting of all suspected adverse events to medicines available in Australia, including prescription medicines, vaccines, over the counter and complementary medicines. The reporting of seemingly insignificant or common adverse events can contribute to the TGA’s investigation of a potential safety signal.

The TGA particularly requests reports of:

  • all suspected reactions to new medicines
  • all suspected medicines interactions
  • unexpected reactions (i.e. those reactions that are not described in the Product Information)
  • suspected reactions causing:
    • death
    • admission to hospital or prolongation of hospitalisation
    • increased investigations or treatment
    • birth defects

Reports of suspected adverse events can be made:

Expert advisory committee

The Advisory Committee on the Safety of Medicines (ACSOM) was established in January 2010 to provide expert advice to the TGA about safety issues under investigation and the appropriateness of Risk Management Plans (RMPs). RMPs outline sponsors’ plans to monitor and communicate risks, and are evaluated as part of the registration process for new medicines. RMPs accompany applications for registration of high risk medicines, such as new chemical entities. RMPs characterise and pro-actively manage risks relating to a medicine over its entire life cycle. ACSOM also provides advice to the TGA on other matters related to pharmacovigilance, including the detection, assessment, understanding and prevention of adverse events.

Medicines Safety Update

The Medicines Safety Update is published six times a year in Australian Prescriber, and also on the TGA website. The Medicines Safety Update replaced the Australian Adverse Drug Reactions Bulletin in 2010.

The following articles were published in Medicines Safety Update in 2011:

  • Clozapine and severe constipation
  • Drug interaction between tamoxifen and antidepressants
  • Methysergide and retroperitoneal fibrosis
  • Thank you for your reports
  • Suspected adverse reactions to vaccines:a reminder to report
  • Drug-induced hyponatraemia
  • Rotavirus vaccination and risk of intussusception: investigation of a possible safety signal
  • Coversyl and Coumadin: new packaging to reduce potential for dispensing errors
  • Risk of hypomagnesaemia with proton pump inhibitors
  • Use of 2011 seasonal influenza vaccines in children
  • Investigation of Prevenar and deaths in children in Japan: what does it mean for Australia?
  • Finding information about adverse reaction reporting on the new TGA website
  • Medicine recalls in Australia
  • Cramps, quinine and thrombocytopenia
  • Venlafaxine and stress cardiomyopathy
  • In utero antipsychotic exposure and neonatal extrapyramidal and withdrawal adverse effects
  • Prescribing medicines in pregnancy - new TGA database
  • Oral contraceptives containing drospirenone (Yaz and Yasmin) and venous thromboembolism
  • Pioglitazone and risk of bladder cancer
  • Modafinil (Modavigil) - safety update
  • Subscribe to TGA email alerts
  • Proton Pump Inhibitors (PPIs) and acute interstitial nephritis
  • Dabigatran (Pradaxa) and the risk of bleeding
  • Reducing the risk of myopathy and rhabdomyolysis with simvastatin - new dosage recommendation

Transparency

Recent reviews of the functions and activities of the TGA have identified a need to ensure the public is aware of the activities undertaken by the TGA to monitor the safety of therapeutic products available to the community. In December 2011 the Government released TGA reforms: a blueprint for TGA’s future (the Blueprint) which included plans to improve the Australian community’s understanding of the TGA’s regulatory processes and decisions and enhance public trust in the safety and quality of therapeutic goods.

The Blueprint consists of a range of interconnected projects the TGA will undertake to achieve more effective and transparent regulation of medicines, meet emerging challenges in the regulation of therapeutic goods and provide more timely information about the goods it regulates.

The TGA applies a risk management approach to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy. Once a therapeutic product is approved, the TGA continues to monitor the product in the market through therapeutic product vigilance activities.

Product vigilance

The aim of therapeutic product vigilance is continually to monitor and evaluate the safety and efficacy (performance) profile of therapeutic products and to manage any risks associated with individual products over the life cycle of a product. The TGA’s therapeutic product vigilance framework is available on the TGA website at www.tga.gov.au/safety/tga-therapeutic-product-vigilance.htm.

The maintenance and improvement of health and safety is a shared responsibility. In addition to government and regulated industry, health professionals, consumers and their respective associations play an important role in reporting therapeutic product safety related issues.

Sponsors have the primary responsibility for the safety of any therapeutic products they import into, supply in or export from Australia. Sponsors must comply with legislative requirements for therapeutic product vigilance under the Therapeutic Goods Act 1989 and there are applicable offences and penalties under the Act for not complying. The legislative requirements for therapeutic product vigilance vary depending on the type of therapeutic good.

The TGA maintains up-to-date safety information on therapeutic products that is communicated through a variety of means to health professionals and consumers. The TGA is committed to advancing public health through the market authorisation of beneficial, innovative therapeutic products and by providing timely, evidence-based and authoritative information to allow consumers and health professionals to make informed decisions.

The TGA defines therapeutic product vigilance tools as tools designed to facilitate the collection and evaluation of information pertaining to the benefits and risks associated with the use of therapeutic products. The main product vigilance tools used by OPR are adverse event reports, Risk Management Plans and Periodic Safety Update Reports (PSURs).

Adverse event reports are reports of any untoward occurrence in a patient administered a medicine and which does not necessarily have a causal relationship with the medicine. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicine, whether or not considered related to this medicine.

RMPs provide a summary of the known important safety information about the therapeutic product, plans to identify and characterise known or potential safety concerns and plans to minimise any identified or potential safety risk. A full outline of the scope of RMPs is above (see Expert advisory committee). PSURs give an annual overview of the safety of the drug, including adverse events, a summary of the registration status of the drug world-wide, actions taken for safety reasons, the world-wide usage of the drug and an analysis of safety requirements. Sponsors must submit PSURs for at least three years after registration of a drug.

An important aspect of product vigilance is ensuring there are mechanisms to communicate safety information to both health professionals and consumers. To achieve this, the TGA publishes Australian Public Assessment Reports (AusPARs) about recently registered prescription medicines on the TGA website. The AusPAR outlines the findings of the TGA’s evaluation of a product including important effectiveness and safety information. The TGA also publishes the Product Information (PI) and Consumer Medicine Information (CMI) for prescription and some non-prescription medicines, Medicines Safety Update and alerts, which provide important information and recommendations about therapeutic goods.

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THE HIGHLY SPECIALISED DRUGS PROGRAMME

Overview

The Australian Government provides funding for certain specialised medications under the Highly Specialised Drugs Programme. Highly specialised drugs (HSDs) 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 prescribe HSDs to provide maintenance therapy under the guidance of the treating specialist.

The Australian Government provides funding for a HSD to be supplied to community based patients, not in-patients of public hospitals; i.e. persons who are day-admitted patients, outpatients and patients upon discharge.

The subsidies for drugs under this programme commences after approval has been given by the Australian Government. For HSDs prescribed through public and private hospitals, claiming and approval of authority prescriptions is administered by the Department of Human Services.

From 1 July 2013, public hospitals transitioned to online claiming arrangements for HSDs (with the exception of clozapine). This transition enables more efficient claiming processes and reduces the administrative burden on public hospitals. In addition, it enables data to be collected at the individual script level rather than summarised at the itemcode level, allowing easier comparison with private hospital data.

Table A: Highly Specialised Drugs—National Usage and Patient Report in Public Hospitals for the period January 2011 to December 2011

Table A - HSD national usage
Drug Name Total Cost ($Aus) Pack Numbers
ABACAVIR $1,573,933 5,683
ABACAVIR + LAMIVUDINE $18,087,292 31,256
ABACAVIR + LAMIVUDINE + ZIDOVUDINE $1,455,722 1,658
ABATACEPT $8,423,165 16,154
ADALIMUMAB $1,351,408 793
ADEFOVIR DIPIVOXIL $4,124,100 7,421
AMBRISENTAN $7,626,514 1,864
APOMORPHINE $2,837,927 34,135
ATAZANAVIR $18,424,121 32,956
AZACITIDINE $9,217,270 16,729
AZITHROMYCIN $66,883 1,168
BACLOFEN $1,187,954 8,009
BOSENTAN $32,875,171 8,045
CIDOFOVIR $5,400 6
CINACALCET $6,611,120 14,465
CLARITHROMYCIN $112,908 2,098
CLOZAPINE $42,706,724 158,474
CYCLOSPORIN $9,693,191 120,431
DARBEPOETIN ALFA $52,611,173 88,973
DARUNAVIR $10,039,593 9,424
DEFERASIROX $13,519,820 16,276
DEFERIPRONE $624,724 1,411
DESFERRIOXAMINE $802,738 16,037
DIDANOSINE $350,454 1,271
DORNASE ALFA $10,126,752 8,578
DOXORUBICIN HYDROCHLORIDE-PEGYLATED LIPOSOMAL $148,895 239
EFAVIRENZ $5,032,726 10,902
ELTROMBOPAG $36,560 15
EMTRICITABINE $155,870 551
ENFUVIRTIDE $462,517 209
ENTECAVIR $11,193,542 26,661
EPOETIN ALFA $20,995,075 31,834
EPOETIN BETA $9,227,218 14,255
EPOETIN LAMBDA $107,736 171
EPOPROSTENOL $1,811,782 22,027
ETANERCEPT $2,572,834 2,608
ETRAVIRINE $3,520,591 5,634
EVEROLIMUS $6,397,008 9,743
FILGRASTIM $12,068,609 7,775
FOSAMPRENAVIR $550,466 1,462
FOSCARNET $1,188 3
GANCICLOVIR $112,014 380
IBANDRONIC ACID $453,667 1,329
ILOPROST $1,829,539 1,657
INDINAVIR $75,553 166
INFLIXIMAB $45,824,399 60,172
INTERFERON ALFA-2A $35,011 981
INTERFERON ALFA-2B $496,788 1,342
INTERFERON GAMMA-1B $471,089 346
LAMIVUDINE $4,040,646 21,074
LAMIVUDINE + ZIDOVUDINE $3,873,947 6,669
LANREOTIDE $6,161,662 3,384
LANTHANUM $1,732,821 4,763
LENALIDOMIDE $27,240,973 4,213
LENOGRASTIM $237,241 276
LEVODOPA + CARBIDOPA ANHYDROUS $127,792 89
LOPINAVIR + RITONAVIR $11,038,876 16,402
MARAVIROC $1,533,798 1,935
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA $4,677,379 7,571
MYCOPHENOLATE $19,958,297 96,292
NATALIZUMAB $26,936,210 13,213
NEVIRAPINE $8,811,745 31,874
OCTREOTIDE $12,294,556 10,696
OMALIZUMAB $249,345 579
PAMIDRONATE DISODIUM $1,240,631 4,658
PEGFILGRASTIM $49,237,207 25,578
PEGINTERFERON ALFA-2A $1,909,230 1,427
PEGINTERFERON ALFA-2A (&) RIBAVIRIN $29,278,215 17,889
PEGINTERFERON ALFA-2B $8,602 4
PEGINTERFERON ALFA-2B (&) RIBAVIRIN $9,877,876 5,238
RALTEGRAVIR $15,265,306 22,738
RIFABUTIN $42,020 286
RITONAVIR $1,841,951 47,521
RITUXIMAB $6,389,339 2,807
ROMIPLOSTIM $4,312,328 2,982
SAQUINAVIR $443,639 850
SEVELAMER $3,265,291 10,533
SILDENAFIL $1,489,525 1,590
SIROLIMUS $2,718,799 3,275
SITAXENTAN $2,744 1
STAVUDINE $188,052 453
TACROLIMUS $21,787,047 64,599
TELBIVUDINE $13,073 52
TENOFOVIR $11,052,302 22,737
TENOFOVIR + EMTRICITABINE $39,701,628 51,121
TENOFOVIR + EMTRICITABINE + EFAVIRENZ $44,233,573 35,714
THALIDOMIDE $7,803,113 15,828
TIPRANAVIR $174,005 162
TOCILIZUMAB $7,611,632 13,838
VALACICLOVIR $219,300 565
VALGANCICLOVIR $13,308,216 6,149
ZIDOVUDINE $313,044 1,444
ZOLEDRONIC ACID $13,609,580 30,239
Grand Total $794,289,288 1,413,083

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SUPPLY OF PHARMACEUTICAL BENEFITS TO REMOTE AREA ABORIGINAL HEALTH SERVICES UNDER SECTION 100 OF THE NATIONAL HEALTH ACT

The S100 Supply Arrangements for Remote Area Aboriginal Health Services (AHSs) improve access to the PBS for clients of remote area 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.

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 (eg chemical and biological stability and sterility) of the pharmaceutical; and
    • comply with any special conditions specified by the manufacturer of the pharmaceutical.

Expenditure

In 2011, 173 remote area Aboriginal Health Services (AHS) were approved to participate in the S100 remote area AHS Program and 162 AHS actually received supply of PBS medicines in that period (note: although approved, some AHS may elect not to participate, or may participate on an intermittent basis). Participating AHS in 2011 were from remote locations in Northern Territory, Queensland, Western Australia, South Australia, New South Wales and Tasmania. S100 remote area AHS expenditure for PBS medicines in 2011 was $44.1 million (GST Inclusive).

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HEALTH EXPENDITURE TRENDS

Table B (i): Total expenditure on pharmaceuticals and other medical non-durables as % total expenditure on health, TEH

Table B (i) - Total expenditure on pharmaceuticals
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Australia 14.8 15.1 14.5 15.0 14.8 14.3 14.3 14.3 14.6 14.7 n.a.
Canada 15.9 16.2 16.7 17.0 17.3 17.2 17.4 17.2 17.0 17.0 16.7
France 16.5 16.9 16.8 16.7 16.8 16.7 16.3 16.4 16.4 16.1 16.0
Germany 13.5 14.1 14.3 14.4 13.8 15.0 14.7 15.0 15.0 14.9 14.8
New Zealand n.a. n.a. n.a. n.a. 10.8 10.7 11.3 10.4 9.7 9.5 9.4
United Kingdom 14.2 13.9 13.5 13.5 13.3 12.8 12.3 12.1 11.8 n.a. n.a.
United States 11.3 11.7 11.9 12.1 12.2 12.2 12.4 12.3 12.1 12.2 11.9

Table B (ii): Total expenditure on pharmaceuticals & other medical non-durables per capita, US$ purchasing power parity

Table B (ii) - Total expenditure on pharmaceuticals
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Australia 336 361 370 400 425 426 453 480 503 541 n.a.
Canada 401 442 478 520 554 593 638 663 679 732 741
France 420 460 490 498 523 551 569 603 613 632 634
Germany 362 397 422 445 438 505 526 559 595 629 640
New Zealand n.a. n.a. n.a. n.a. 213 227 270 254 261 279 285
United Kingdom 260 278 296 313 337 346 363 366 369 n.a. n.a.
United States 540 600 665 727 778 819 881 920 941 977 983

Table B (iii): Total expenditure on health as % gross domestic product

Table B (iii) - Total expenditure on health
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Australia 8.0 8.1 8.4 8.3 8.5 8.4 8.5 8.5 8.7 9.1 n.a.
Canada 8.8 9.3 9.6 9.8 9.8 9.8 10.0 10.0 10.3 11.4 11.4
France 10.1 10.2 10.6 10.9 11.0 11.2 11.0 11.0 11.0 11.7 11.6
Germany 10.4 10.5 10.7 10.9 10.7 10.8 10.6 10.5 10.7 11.7 11.6
New Zealand 7.6 7.7 8.0 7.9 8.0 8.4 8.8 8.5 9.3 10.0 10.1
United Kingdom 7.0 7.3 7.6 7.8 8.0 8.2 8.5 8.5 8.8 9.8 9.6
United States 13.7 14.3 15.1 15.7 15.8 15.8 15.9 16.2 16.6 17.7 17.6

Legend
n.a.: Not available (data not provided to the Organisation for Economic Co-operation and Development (OECD) by these countries for these years)
Sources: OECD Health Data 2012—Version June 2012

(a) ‘Pharmaceuticals’ defined

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. Pharmaceuticals dispensed to, or used by admitted patients in hospital are not included.

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.

Expenditure by private households or over-the-counter medicines (OTC medicines) is included in pharmaceutical expenditure.

Other medical non-durables comprise items such as bandages, elastic stockings, incontinence articles, condoms and other mechanical contraceptive devices.

Pharmaceutical expenditure is also reported in Health Expenditure Australia 2009-10. In this report, the Australian Institute of Health and Welfare (AIHW) splits medication expenditure into two categories, ‘benefit paid pharmaceuticals’ and ‘all other medications’.

‘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 medications’ are medications for which no PBS or RPBS benefit was paid and includes the following components, which are reported separately:

  • 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 or which do not meet PBS criteria for dispensing through the PBS; and
  • over-the-counter medicines such as aspirin, cough and cold medicines, vitamins and minerals, some herbal and other complementary medicines and medical non-durable goods, as listed above.

Under the AIHW definitions used in Health expenditure Australia, highly specialised drugs are included as part of hospital expenditure, not as part of medications expenditure. Under the OECD definition, highly specialised drugs are included in ‘Pharmaceutical’ expenditure.

(b) Health expenditure recorded here is according to the OECD definition and excludes health research expenditure.

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DRUG UTILISATION TRENDS

Anatomical Therapeutic Chemical (ATC) classification index with Defined Daily Doses (DDDs) 2012 is used in all statistics published in this edition (refer to WHO collaborating Centre for Drug Statistics Methodology, ATC classification index with DDDs 2012).

Listed below are the prescription counts for 2009, 2010 and 2011 by ATC anatomical main group. The data from the two sources are enumerated separately. Table C (i) shows subsidised prescriptions (PBS/RPBS) and Table C (ii) shows the estimate of nonsubsidised prescriptions (Survey).

Tables C: Prescription numbers by ATC groups

Table C (i): Subsidised prescriptions (PBS/RPBS)

Table C(i) - subsidised prescriptions
ATC Group 2009 2010 2011
(A) Alimentary Tract 28,400,464 28,934,869 28,741,866
(B) Blood and blood forming 8,640,003 8,961,287 9,011,672
(C) Cardiovascular system 67,302,312 69,501,887 71,052,963
(D) Dermatologicals 2,980,367 3,044,864 3,100,758
(G) Genitourinary system 3,172,962 3,016,920 3,054,098
(H) Hormonal preparations 2,906,146 3,028,197 3,107,836
(J) Antiinfectives 13,546,581 13,603,470 14,086,713
(L) Antineoplastic 2,098,520 2,282,769 2,400,647
(M) Musculo-skeletal 9,262,036 9,044,116 8,871,353
(N) Nervous system 38,838,056 41,109,237 43,141,389
(P) Antiparasitic products 583,591 619,618 662,647
(R) Respiratory system 10,544,777 10,924,181 11,222,832
(S) Sensory Organs 8,718,735 8,826,316 8,839,667
(V) Various 646,443 627,657 614,535
Other 209,959 234,134 237,869
Total 197,850,952 203,759,522 208,146,845

Table C (ii): Estimated non-subsidised prescriptions (Survey)

Table C(ii) - estimated non-subsidised prescriptions
ATC Group 2009 2010 2011
(A) Alimentary Tract 5,394,413 5,443,423 6,778,526
(B) Blood and blood forming 826,678 799,144 795,439
(C) Cardiovascular system 13,069,382 12,749,658 12,459,359
(D) Dermatologicals 2,998,874 3,090,690 3,107,951
(G) Genitourinary system 7,319,091 7,241,951 7,237,305
(H) Hormonal preparations 1,600,906 1,673,213 1,709,388
(J) Antiinfectives 15,530,330 15,262,828 15,802,547
(L) Antineoplastic 118,612 134,160 150,004
(M) Musculo-skeletal 3,168,661 3,088,987 3,106,030
(N) Nervous system 12,106,849 12,179,569 12,804,813
(P) Antiparasitic products 691,724 671,856 688,164
(R) Respiratory system 2,696,789 2,648,049 2,586,732
(S) Sensory Organs 2,400,492 2,294,943 2,155,669
(V) Various 19,842 21,220 26,030
Other 220,046 232,186 245,644
Total 68,162,689 67,531,877 69,653,601

Estimated changes from 2002 to 2011 in the number of prescriptions dispensed under the PBS (concession and general), RPBS, under co-payment and private categories, are presented in Figure C.

Figure C: Number of prescriptions by type of service

Figure C : Number of prescriptions by type of service

 

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Most commonly used drugs in the Australian community for 2011

Table D shows the top 10 drugs dispensed in the Australian community by DDDs/1000 population/day, which adjusts for the quantity dispensed per prescription. This DDDs/1000/day information shows both the subsidised (PBS/RPBS) and non-subsidised (Guild survey) components, as well as total community use. Changes and alterations from the previous years are also shown.

Table D: Top 10 drugs by defined daily dose/thousand population/day, 2011 (including the contribution of constituents of combination products)

Table D - Top 10 drugs by daily dose
Drug PBS/RPBS Guild Survey Total
ATORVASTATIN 85.043 0.139 85.182
IRBESARTAN 33.007 10.187 43.194
PERINDOPRIL 31.124 11.129 42.253
ROSUVASTATIN 36.158 0.067 36.225
RAMIPRIL 25.910 8.813 34.723
CANDESARTAN 26.960 5.265 32.225
PARACETAMOL 28.990 2.559 31.549
AMLODIPINE 22.105 3.991 26.096
SIMVASTATIN 23.654 0.672 24.325
ESOMEPRAZOLE 21.454 2.700 24.154

Changes from 2010:

Changes from 2010 in Top 10 drugs by dosage
UP: Rosuvastatin (5 Arrow 4)
Amlodipine (9Arrow  8)
DOWN: Ramipril (4 Arrow 5)
Simvastatin (8 Arrow 9)

 

The top 10 drugs dispensed in the Australian community in 2011, ranked by prescription count, are shown in table E. Table F ranks the 2011 top 10 drugs by total cost to Australia, i.e. subsidised prescriptions only (total cost is the sum of patient contribution and cost to Government).

Table E: Top 10 drugs by prescription counts, 2011

Table E - Top 10 drugs by prescription counts
Drug PBS/RPBS Guild Survey Total Community use
ATORVASTATIN 11,100,222 20,422 11,120,644
ESOMEPRAZOLE 5,890,893 1,088,070 6,978,963
ROSUVASTATIN 6,595,316 12,321 6,607,637
AMOXYCILLIN 2,592,120 3,670,480 6,262,600
PARACETAMOL 5,181,539 276,598 5,458,137
PERINDOPRIL 3,971,080 1,468,112 5,439,192
CEFALEXIN 2,740,226 2,380,837 5,121,063
PANTOPRAZOLE 3,700,004 844,942 4,544,946
METFORMIN HYDROCHLORIDE 3,432,146 1,092,602 4,524,748
AMOXYCILLIN with CLAVULANIC ACID 2,014,812 2,376,545 4,391,357

Changes from 2010:

Changes from 2010 in top 10 drugs by prescription counts
UP: Rosuvastatin (5 Arrow 3)
Paracetamol (6 Arrow 5)
Pantoprazole (10 Arrow 8)
DOWN: Amoxycillin (3 Arrow 4)
Perindopril (4 Arrow 6)
IN: Amoxycillin with Clavulanic acid (13 Arrow 10)
OUT: Simvastatin (8 Arrow 12)

Table F: Top 10 PBS/RPBS drugs by total cost to Australia, 2011

Table F - Top 10 PBS / RPBS drugs by total cost
Drug PBS/RPBS
DDD/1000/DAY 		PBS/RPBS
Scripts 		Total Cost
($)
ATORVASTATIN 85.043 11,100,222 784,927,075
ROSUVASTATIN 36.158 6,595,316 467,425,285
RANIBIZUMAB 160,813 342,880,160
ESOMEPRAZOLE 21.454 5,890,893 230,060,391
SALMETEROL and FLUTICASONE 3,124,942 221,699,121
ADALIMUMAB 0.368 107,020 192,726,034
CLOPIDOGREL 11.179 2,706,737 187,035,815
OLANZAPINE 3.084 967,080 174,280,242
SIMVASTATIN 23.654 4,087,534 161,894,597
VENLAFAXINE 12.150 2,598,159 140,328,907

No information on cost for private and under co-payment prescriptions is available.

Changes from 2010:

Change from 2010 in the top 10 PBS drugs by total cost
UP: Salmeterol and Fluticasone (6 Arrow 5)
Adalimumab (9 Arrow 6)
DOWN: Clopidogrel (5 Arrow 7)
Simvastatin (7 Arrow 9)

Figure D shows the top 10 subsidised drugs dispensed in 2011.

Figure D: Top 10 subsidised drugs dispensed in 2011

Figure D : Top 10 subsidised drugs dispensed in 2011

Figure E represents the top 10 non-subsidised drugs for 2011.

Figure E: Top 10 non-subsidised drugs dispensed in 2011

Figure E : Top 10 non-subsidised drugs dispensed in 2011

Nurse Prescribing

From 1 November 2010, authorised nurse practitioners can write PBS/RPBS prescriptions listed in the PBS Schedule with a flag of “NP”. Medicines without this flag are not to be prescribed by authorised nurse practitioners. Refer to Schedule of Pharmaceutical Benefits available on the PBS website for details of subsidised medicines.

Information for how nurse practitioners can become authorised PBS prescribers is available from the Department of Human and Services website.

Table G shows the top 10 PBS/RPBS drugs prescribed by nurse practitioners and dispensed in 2011. Table H ranks the 2011 top 10 drugs prescribed by total cost.

Table G: Nurse Practitioner—Top 10 PBS/RPBS drugs by prescription counts, 2011

Table G : nurse practitioner - top 10 PBS drugs by prescription counts
Drug PBS/RPBS Scripts
CEPHALEXIN 1,137
ATORVASTATIN 1,013
AMOXYCILLIN with CLAVULANIC ACID 750
CODEINE PHOSPHATE with PARACETAMOL 732
OXYCODONE HYDROCHLORIDE 713
PARACETAMOL 685
AMOXYCILLIN 635
FLUCLOXACILLIN 549
ROSUVASTATIN 536
FLUTICASONE PROPIONATE with SALMETEROL XINAFOATE 523

Table H: Nurse Practitioner—Top 10 PBS/RPBS drugs prescribed by total cost, 2011

Table H : nurse practitioner - top 10 PBS drugs by total cost
Drug Total Cost ($)
ATORVASTATIN 72,512
RISPERIDONE 69,855
PANCREATIC EXTRACT 67,913
OLANZAPINE 46,693
QUETIAPINE 37,390
ROSUVASTATIN 37,185
FLUTICASONE PROPIONATE with SALMETEROL XINAFOATE 35,858
VALACICLOVIR 26,348
INSULIN GLARGINE 24,006
POSACONAZOLE 23,109

Optometrist Prescribing

Since 1 January 2008, authorised optometrists are able to prescribe medicines listed in the optometrist section of the Pharmaceutical Benefits Schedule. Refer to Pharmaceutical Benefits Schedule for a list of medicines that can be prescribed by authorised optometrists.

Table I shows the top 10 PBS/RPBS drugs prescribed by optometrists and dispensed in 2011. Table H ranks the 2011 top 10 drugs prescribed by total cost.

Table I: Optometrist—Top 10 PBS/RPBS drugs by prescription counts, 2011

Table I - Optometrist top 10 drugs by prescription count
Drug PBS/RPBS Scripts
LATANOPROST 8,022
POLYETHYLENE GLYCOL 400 with PROPYLENE GLYCOL 7,754
CHLORAMPHENICOL 5,781
FLUOROMETHOLONE 4,864
CARMELLOSE SODIUM 3,635
HYPROMELLOSE 2,244
LATANOPROST with TIMOLOL MALEATE 2,031
HYPROMELLOSE with CARBOMER 980 1,983
PARAFFIN 1,760
FLUOROMETHOLONE ACETATE 1,704

Table J: Optometrist—Top 10 PBS/RPBS drugs prescribed by total cost, 2011

Table J - Optometrist top 10 drugs by total cost
Drug Total Cost ($)
LATANOPROST 338,041
LATANOPROST with TIMOLOL MALEATE 94,649
POLYETHYLENE GLYCOL 400 with PROPYLENE GLYCOL 91,663
CHLORAMPHENICOL 60,839
CARMELLOSE SODIUM 60,402
BIMATOPROST 57,479
FLUOROMETHOLONE 51,607
TRAVOPROST 41,466
PARAFFIN 35,296
BIMATOPROST with TIMOLOL MALEATE 27,074

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TABLES IN THE AUSTRALIAN STATISTICS ON MEDICINES

The data are presented in two major tables. Table 1 provides an estimate of the 2011 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 co-payment PBS prescriptions. Cost information on the dispensing of private prescriptions is not available. The defined daily dose (DDD), where available, is also included for the drugs covered in the report.

Table 2 includes community prescription drug use, in DDDs/1000 population/day, for the years 2009, 2010 and 2011. In this edition, DDDs/1000 population/day for combination products is also reported in terms of DDDs of each constituent. One main advantage of reporting combinations as if they were administered as two or more single component products is that total DDDs remain constant as patients switch to combination products, if the amounts of constituent drugs consumed by patients remain the same.

Note that not all combination products are included in table 2. Combination drugs will only be reported in terms of DDD of each constituent where:

  • the constituent drugs were available as plain drugs on the PBS;
  • the combination was a frequently prescribed form;
  • the constituent drugs had independent actions; and
  • the WHO Defined Daily Dose was consistent across the various formulations of the constituent drugs.

Anatomical Therapeutic Chemical (ATC) classification index with Defined Daily Doses (DDDs) 2012 is used in statistics published in this edition (refer to WHO collaborating Centre for Drug Statistics Methodology, ATC classification index with DDDs 2012).

 

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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): 427432.

(2) Hurley SF, McNeil JJ. Drugcoding 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.

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CAVEATS

It needs to be borne in mind that these utilisation data do not include a large proportion of public hospital drug usage, over the counter purchases (except for S3 Recordable), or the supply of highly specialised drugs to outpatients 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:

Alicia Segrave
Secretary
Drug Utilisation Sub-Committee (DUSC)
Department of Health
GPO Box 9848
CANBERRA ACT 2601.

e-mail: DUSC@health.gov.au

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GLOSSARY OF TERMS

Glossary of terms
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

 

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Weights and Measures

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 micrograms(s)

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ATC & DDD ADDITIONS AND ALTERATIONS

Alterations in ATC classification

Alterations in ATC classification
Drug/drug group Previous ATC code New ATC code
C1-inhibitor, plasma derived* B02AB03 B06AC01
Icatibant C01EB19 B06AC02
Alitretinoin D11AX19 D11AH04

*New 5th level name

Alterations in ATC level classification

Alteration in ATC level classification
ATC code Previous ATC level name New ATC level name
A12AX Calcium, combinations with other drugs Calcium, combinations with vitamin D and/or other drugs
B06AC Drugs used in hereditary angioedema
D11AH Agents for atopic dermatitis, excluding corticosteroids Agents for dermatitis, excluding corticosteroids
G04CX01 Pygeum africanum Prunus africanae cortex
G04CX02 Serenoa repens Sabalis serrulatae fructus
H01CB Antigrowth hormones Somatostatin and analogues
J07AH03 Meningococcus, bivalent purified polysaccharides antigen Meningococcus A,C, bivalent purified polysaccharides antigen
J07AH04 Meningococcus, tetravalent purified polysaccharides antigen Meningococcus A, C, Y, W - 135, tetravalent purified polysaccharides antigen
J05AH08 Meningococcus, tetravalent purified polysaccharides antigen conjugated Meningococcus A, C, Y, W - 135, tetravalent purified polysaccharides antigen conjugated
L02BG Enzyme inhibitors Aromatase inhibitors
N05CM09 Valerian Valerianae radix
N06DX02 Ginkgo biloba Ginkgo folium
R05X Other cold combination preparations Other cold preparations

Allocation of new ATC codes

Allocation of new ATC codes
New ATC Code ATC level name
A02BC06 Dexlansoprazole
A10BD10 Metformin and saxagliptin
A10BD11 Metformin and linagliptin
A10BX09 Dapagliflozin
A16AX08 Teduglutide
B01AA12 Fluindione
B02BD10 Von willebrand factor
B02BD11 Catridecacog
B06AC03 Ecallantide
B06AC04 Conestat alfa
C05CX03 Hippocastani semen
C09BB07 Ramipril and amlodipine
C09CA09 Azilsartan medoxomil
C09DB06 Losartan and amlodipine
C10AX11 Mipomersen
D03AX11 Tetrachlorodecaoxide
D06BB12 Sinecatechins
G03DB08 Dienogest
G04BX15 Pentosan polysulfate sodium
H01AC06 Tesamorelin
H01CB05 Pasireotide
J01CA19 Aspoxicillin
J01DC12 Cefminox
J01DC13 Cefbuperazone
J01DC14 Flomoxef
J01DF02 Carumonam
J01GB13 Bekanamycin
J05AE11 Telaprevir
J05AG05 Rilpivirine
J06BB17 Motavizumab
J07AH09 Meningococcus B, multicomponent vaccine
L01CD04 Cabazitaxel
L01XC11 Ipilimumab
L01XC12 Brentuximab vedotin
L01XE14 Bosutinib
L01XE15 Vemurafenib
L01XE16 Crizotinib
L01XE17 Axitinib
L01XE18 Ruxolitinib
L01XX42 Panobinostat
L02BX03 Abiraterone
L03AX17 Sipuleucel-T
L04AC10 Seculinumab
L04AX05 Pirfenidone
M01AC56 Meloxicam, combinations
M01AE56 Naproxen and misoprostol
N03AX22 Perampanel
N05AX14 Iloperidone
N06AX24 Vilazodone
N06AX25 Hyperici herba
N06DA52 Donepezil and memantine
N07BC05 Levomethadone
N07XX08 Tafamidis
P03AX05 Dimeticone
R06AA59 Doxylamine, combinations
S01LA05 Aflibercept
S02DA04 Cinchocaine

Allocation of new DDDs

Allocation of new DDDs
ATC level name ATC code New DDD
A03AE04 Prucalopride 2 mg O
A16AB10 Velaglucerasa alfa 300 U P
B01AC24 Ticagrelor 0.18 g O
B02BX05 Eltrombopag 50 mg O
B06AC04 Conestat alfa 3.5 TU P
C01BG11 Vernakalant 0.2 g P
G03DB08 Dienogest 2 mg O
G03GA09 Corifollitropin alfa 0.15 mg P
H01CA03 Histrelin 0.137 g2) implant
J01CA19 Aspoxicillina 4 g P
J01DC12 Cefminox 4 g P
J01DC13 Cefbuperazone 2 g P
J01DC14 Flomoxef 2 g P
J01DF01 Aztreonam 0.225 g Inhal. solution
J01DF02 Carumonam 2 g P
J01GB10 Ribostamycin 1 g P
J01GB11 Isepamicin 0.4 g P
J01GB13 Bekanamycin 0.6 g P
L03AX15 Mifamurtide 0.7 mg P
L04AA27 Fingolimod 0.5 mg O
M01AB51 Indomethacin, combinations 0.1 g1) O,R
N02AX06 Tapentadol 0.4 g O
N02BG07 Flupirtine 0.4 g O
N05AH05 Asenapine 20 mg O
N06AX23 Desvenlafaxine 50 mg O
N07XX07 Fampridine 20 mg O
R03AC18 Indacaterol 0.15 mg Inhal. powder
R03DX07 Roflumilast 0.5 mg O

1) refers to indomethacin
2) DDD assigned according to the total content of the implant

Full details on current ATC coding and defined daily doses (DDDs) can be obtained from the DUSC Secretary, Department of Health, GPO Box 9848, Canberra ACT 2601, or direct from the coordinating body: the WHO Collaborating Centre for Drug Statistics Methodology, Norwegian Institute of Public Health, PO BOX 4404 Nydalen 0403 Oslo Norway, or at the WHO website.