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Australian Statistics on Medicines 2012

Page last updated: 7 March 2016

Acknowledgments

Prepared by Gareth Thomas, Chris Raymond 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:

  • Dr Katherine Gray, Advisory Committee on the Safety of Medicines, Therapeutic Goods Administration.
  • Rebecca Bennetts, Australian Institute of Health and Welfare.
  • Adam Majchrzak-Smith, Australian Institute of Health and Welfare
  • David Nott, Pharmaceutical Access, Department of Health.
  • The World Health Organization Collaborating Centre for Drug Statistics Methodology.

Australian Statistics on Medicine 2012

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Contents

Introduction

The data contained in the 2012 Australian Statistics on Medicines are drawn from two sources. The first is the Department of Human Services (DHS) 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 2012 prescription numbers for both subsidised and under copayment prescriptions. 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.  The under-copayment prescription volumes reported in this ASM is a combination of the Guild Survey based estimate from January 2012 to March 2012 (inclusive) combined with the DHS collected actual under-copayment prescription volumes from April to December 2012 (inclusive). Table 2 includes community prescription drug use, in DDDs/1000 population/day, for the years 2010, 2011 and 2012. Table 2 reports the DDDs for each drug, reporting the use in monocomponent (‘plain’) and in fixed dose combination formulations.  Please note that the Pharmacy Guild Survey data ceased during 2012 therefore estimates of private prescription volumes are not available in 2012 data.

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 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 2012, general patients paid the cost of a prescription up to a maximum of $35.40. Pensioner and concession patients paid $5.80 per prescription.

In addition, there is a Safety Net Scheme to protect people with high medication needs. In 2012, once general patients and/or their immediate family incurred $1,363.30 of PBS expenditure (indexed), PBS/RPBS prescriptions for the remainder of the calendar year cost only $5.80 per prescription. Once pensioners and other concession card holders reached the concession safety net threshold of $348 expenditure (indexed), they received all remaining prescriptions in 2012 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 2012, under co-payment general prescriptions represented around 21% 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.

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.

Further information is available on the PBS website.

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.

Further information is available on the PBS website.

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 Department of Health website.

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:

  • anatomical main group
  • pharmacological/therapeutic subgroup
  • chemical/pharmacological or therapeutic subgroup
  • chemical/pharmacological or therapeutic subgroup
  • chemical substance (generic drug name)

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

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:

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 2014 are included in the Anatomical Therapeutic Chemical Index (ATC) & Defined Daily Dose (DDD) additions and alterations section in this publication.

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:

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 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.

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

On 1 April 2012, DHS started collecting actual under-copayment prescriptions and these were also provided to the Department of Health along with the PBS/RPBS subsidised prescription data. The under-copayment prescription volumes reported in this ASM is a combination of the Guild Survey (see below) based on estimate from January 2012 to March 2012 (inclusive) combined with the DHS collected actual under-copayment prescription volumes from April 2012 to December 2012 (inclusive).

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.

Estimates of private prescription volumes are not included in the 2012 data throughout this edition. The Pharmacy Guild Survey data, and therefore private prescription volume estimates, ceased at the end of August 2012. Private prescription estimates were excluded from this ASM because data was only available for part of 2012 (ie. from January to August 2012). Unlike under-copayment data, an alternative source of private script data was not available to complete the year, thus it was removed to avoid reporting a potentially misleading part-year of data.

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.

Adverse event reporting in Australia in 2012

The TGA's reporting system for adverse events began in the late 1960s with the computerised database dating back to the early 1970s. During 2012 the 250,000th report was received and by the end of the year there were approximately 261,000 reports of suspected adverse events in the database.

Figure B: Origin of adverse event reports received by the TGA (2006-2012)

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

In 2012 the TGA received approximately 14,300 reports of adverse events. Approximately 57% of these were from pharmaceutical companies, 11% from hospitals (including hospital pharmacists), 5% from general practitioners (GPs), 13% from State and Territory health departments, 7% from community pharmacists and 4% from consumers (Figure 1).

Adverse event reports from pharmaceutical companies continued to rise in 2012, continuing a four-year trend. Reports from State and Territory health departments continued to fall after a spike in 2009-10 due to safety issues with influenza vaccines but have continued to remain above the number reported prior to 2009. Health professionals are encouraged to report suspected adverse events directly to the TGA rather than through the sponsor or manufacturer to simplify communication.

In 2012 MIMs, in association with the TGA, introduced a new mechanism for health professionals to submit adverse event reports via MIMS online.

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 assesses causality of adverse event(s) and in some cases requests further clinical or laboratory information from the reporter. 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 World Health Organization 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 more than 80 nations with more than 7 million reports in the database.

Database of adverse events notifications

The TGA introduced the publicly searchable Database of Adverse Event Notifications (DAEN) in 2012.

Information in the DAEN comes from reports made to the TGA by a wide range of sources, including members of the public, general practitioners, nurses, other health professionals and the therapeutic goods industry. Reports in this database start from 1 January 1971 up to three months prior to the date of access. The TGA uses this three-month period to investigate each adverse event report.

The DAEN was created to support better health outcomes by providing access to the information that the TGA gathers while monitoring medicine and vaccine safety in Australia.

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.

Sponsors of all medicines and vaccines on the Australian Register of Therapeutic Goods (ARTG) have mandatory reporting requirements regarding adverse events.

The TGA particularly requests reports of:

  • Suspected adverse events involving new medicines and vaccines
  • Suspected drug interactions
  • Unexplained adverse events (i.e. reactions that are not described in the Product Information)
  • Serious adverse events, such as those suspected of causing:
  • Inability to work
  • Admission to hospital
  • Prolongation of hospitalisation
  • Increased investigation or treatment costs
  • Danger to life
  • Birth defects
  • Death.

Reports of suspected adverse events can be made:

  • online by following the link to 'Report a Problem'
  • health professionals can submit a report directly from MIMS online
  • using a 'Blue Card' available from the TGA's Office of Product Review (1800 044 114 or adr.reports@tga.gov.au) or downloaded from the TGA website at 'Blue card' adverse reaction reporting form.

Expert advisory committee

Advisory Committee on the Safety of Medicines

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.

Advisory Committee on the Safety of Vaccines

The government’s Review of the management of adverse effects associated with Panvax and Fluvax (the Horvath Review), amongst other things, included a recommendation to establish a working party to review governance of the vaccine safety system. Following a recommendation from the Horvath Review Implementation Steering Committee in 2012 “to consider the current governance arrangements for monitoring and responding to vaccine safety issues in Australia and make recommendations for an improved system of governance for vaccine safety monitoring” the Advisory Committee on the Safety of Vaccines (ACSOV) was established in the Therapeutic Goods Regulations.  The functions of ACSOV are to provide advice and make recommendations to the Minister for Health, the TGA and the Office of Health Protection on the safety, risk assessment and risk management of vaccines.

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 2012:

  • Ondansetron and QTc interval prolongation – dosing change
  • Domperidone (Motilium) – serious ventricular arrhythmias and sudden cardiac death
  • Cardiovascular safety risk with fingolimod (Gilenya) – updates to the Product Information
  • Disposal of unwanted medicines
  • Changes to over-the-counter cough and cold medicines for children
  • Post-market vigilance and introduction of the Database of Adverse Event Notifications
  • Lenalidomide (Revlimid) and second primary malignancy
  • Kogenate: home use Factor VIII and filtration
  • Accidental paracetamol poisoning
  • Strontium ranelate and venous thromboembolism and serious skin reactions
  • Better information on medicine labels – have your say.
  • Candesartan, fetal malformations and use in pregnancy
  • Zolpidem: continued reporting of abnormal sleep-related events and amnesia
  • Renal function assessment in prescribing
  • Anaphylaxis with chlorhexidine-impregnated central venous catheters
  • Change in the pregnancy category for topiramate
  • Use of 2012 seasonal influenza vaccines in children
  • Dasatinib (Sprycel) and pulmonary arterial hypertension
  • Pulmonary oedema associated with topical phenylephrine
  • Pneumovax 23 – updated revaccination recommendations
  • Caveat emptor 'buyer beware' – the risks of purchasing unregistered medicines online
  • Citalopram and QT prolongation – important changes to the dosing recommendations
  • Atomoxetine (Strattera) – risk of increased blood pressure and/or heart rate

Transparency

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.

As at 31 December 2012, implementation of eleven recommendations had been completed and, of these, the following related to product vigilance:

  • Publication of the TGA External Communication and Education Framework: Priorities and projects 2013-15
  • Publication of a clear explanation of the TGA's risk based framework on the TGA website
  • Publication of further information on the role of TGA statutory advisory committees and clarification of their reporting arrangements.
  • In addition, by 31 December 2012 work had been completed to address aspects of other recommendations. This work included:
  • Conduct of a pilot project to investigate how the TGA might more effectively respond to phone and email enquiries
  • Release of an online system for reporting problems with medical devices
  • Provision of access by consumers, health professionals and industry to online information on adverse events which have been reported to the TGA relating to medicines
  • Provision of public access to Australian and New Zealand adverse event data for medicines, hosted on ANZTPA.org
  • Work towards the establishment of an Advisory Committee on the Safety of Vaccines (ACSOV), under the Therapeutic Goods Regulations 1990.

Product vigilance

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.

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 Therapeutic product vigilance.

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, RMPs 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.

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 2012 to December 2012

Drug Name Total cost ($Aus) Pack Numbers
ABACAVIR $1,565,545 5,737
ABACAVIR + LAMIVUDINE $18,905,390 34,696
ABACAVIR + LAMIVUDINE + ZIDOVUDINE $1,236,042 1,482
ABATACEPT $7,598,105 14,061
ADALIMUMAB $2,211,882 1,325
ADEFOVIR DIPIVOXIL $3,402,338 5,444
AMBRISENTAN $10,125,743 2,487
APOMORPHINE $3,033,799 29,437
ATAZANAVIR $18,814,183 34,305
AZACITIDINE $17,071,461 30,976
AZITHROMYCIN $68,184 1,197
BACLOFEN $1,274,261 8,596
BOSENTAN $35,536,329 8,727
CIDOFOVIR $17,100 19
CINACALCET $6,168,308 13,520
CLARITHROMYCIN $90,315 1,813
CLOZAPINE $35,521,982 172,500
CYCLOSPORIN $9,622,518 118,302
DARBEPOETIN ALFA $55,965,427 95,696
DARUNAVIR $12,261,419 12,978
DEFERASIROX $14,678,073 17,384
DEFERIPRONE $561,997 1,247
DESFERRIOXAMINE $788,656 15,315
DIDANOSINE $291,851 1,047
DORNASE ALFA $11,353,079 9,621
DOXORUBICIN HYDROCHLORIDE-PEGYLATED LIPOSOMAL $62,922 101
EFAVIRENZ $3,192,079 10,090
ELTROMBOPAG $1,409,398 618
EMTRICITABINE $190,311 675
EMTRICITABINE + RILPIVIRINE + TENOFOVIR $3,334,519 3,217
ENFUVIRTIDE $362,932 164
ENTECAVIR $12,665,582 30,629
EPOETIN ALFA $19,407,860 29,866
EPOETIN BETA $7,568,782 11,429
EPOETIN LAMBDA $264,836 447
EPOPROSTENOL $2,281,297 28,171
ETANERCEPT $2,247,873 2,220
ETRAVIRINE $3,918,258 6,356
EVEROLIMUS $5,995,631 8,741
FILGRASTIM $12,411,518 8,476
FOSAMPRENAVIR $481,637 1,303
GANCICLOVIR $97,258 327
IBANDRONIC ACID $248,851 729
ILOPROST $2,005,256 1,811
INDINAVIR $78,636 173
INFLIXIMAB $51,526,882 67,791
INTERFERON ALFA-2A $18,772 546
INTERFERON ALFA-2B $341,602 976
INTERFERON GAMMA-1B $403,507 297
LAMIVUDINE $3,574,536 19,992
LAMIVUDINE + ZIDOVUDINE $3,307,679 5,908
LANREOTIDE $7,075,420 3,870
LANTHANUM $2,230,648 6,064
LENALIDOMIDE $32,508,760 5,047
LENOGRASTIM $256,272 271
LEVODOPA + CARBIDOPA ANHYDROUS $216,603 150
LOPINAVIR + RITONAVIR $10,221,399 15,460
MANNITOL $130,634 301
MARAVIROC $1,784,871 1,945
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA $8,022,550 13,429
MYCOPHENOLATE $18,664,434 99,423
NATALIZUMAB $30,611,554 15,017
NEVIRAPINE $8,892,750 33,298
OCTREOTIDE $13,835,802 11,537
OMALIZUMAB $1,755,046 4,070
PAMIDRONATE DISODIUM $1,116,415 4,215
PEGFILGRASTIM $51,486,801 26,748
PEGINTERFERON ALFA-2A $1,911,466 1,424
PEGINTERFERON ALFA-2A (&) RIBAVIRIN $25,740,110 15,739
PEGINTERFERON ALFA-2B (&) RIBAVIRIN $13,636,492 7,220
RALTEGRAVIR $20,658,435 31,040
RIFABUTIN $43,778 298
RILPIVIRINE $68,167 251
RITONAVIR $2,163,114 52,776
RITUXIMAB $7,114,021 3,127
ROMIPLOSTIM $6,514,392 4,565
SAQUINAVIR $363,584 719
SEVELAMER $3,145,032 10,145
SILDENAFIL $1,669,662 1,785
SIROLIMUS $2,671,904 3,209
STAVUDINE $152,450 370
TACROLIMUS $23,731,202 72,589
TADALAFIL $189,458 218
TELBIVUDINE $15,500 62
TENOFOVIR $13,674,100 28,305
TENOFOVIR + EMTRICITABINE $44,682,049 58,400
TENOFOVIR + EMTRICITABINE + EFAVIRENZ $44,597,461 41,291
THALIDOMIDE $8,064,104 15,824
TIPRANAVIR $137,088 128
TOCILIZUMAB $11,418,266 21,810
TRASTUZUMAB $5,344,076 7,147
VALACICLOVIR $266,900 632
VALGANCICLOVIR $15,054,283 7,086
ZIDOVUDINE $267,837 1,388
ZOLEDRONIC ACID $11,664,338 25,921
Grand Total $859,331,629 1,533,281

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

  • The health service must have a primary function of meeting the health care needs of Aboriginal and Torres Strait Islander peoples.
  • 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.
  • 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.
  • 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.
  • 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.

Further information is available on the Department of Health website.

Expenditure

In 2012, 173 remote area Aboriginal Health Services (AHS) were approved to participate in the Remote Area Aboriginal Health Services (RAAHS) Programme 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 2012 were from remote locations in Northern Territory, Queensland, Western Australia, South Australia, New South Wales and Tasmania.  RAAHS Programme expenditure on PBS medicines in 2012 was $43.8 million. 

Health Expenditure Trends

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

Year

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012
Country

 

 

 

 

 

 

 

 

 

 
Australia 14.6 14.4 14.0 14.0 13.9 14.0 14.2 14.2 13.8 13.8
Canada 17.0 17.2 17.2 17.4 17.2 17.0 17.0 16.6 17.1 ..
France 16.9 16.9 16.9 16.7 16.7 (B) 16.5 16.2 16.0 15.6 15.2
Germany 14.4 13.8 15.0 14.7 15.0 15.0 14.9 14.7 14.1 13.9
New Zealand .. 10.8 10.7 11.3 10.4 9.7 9.5 9.5 9.4 ..
United Kingdom 13.4 13.3 12.8 12.3 12.0 11.5 .. .. .. ..
United States 12.2 12.4 12.3 12.6 12.6 12.3 12.4 12.0 11.9 11.5

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

Year

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012
Country

 

 

 

 

 

 

 

 

 

 
Australia 394.9 420.3 423.0 449.6 464.2 518.5 524.3 557.6 569.1 589.4
Canada 520.2 554.0 592.7 638.9 662.5 678.9 729.0 736.3 771.3 ..
France 496.0 519.3 544.8 569.5 594.6 (B) 613.5 639.8 644.5 655.2 651.0
Germany 445.1 438.2 505.4 526.6 558.6 595.7 628.3 651.5 649.5 668.0
New Zealand .. 212.9 227.3 270.4 253.5 261.2 283.8 286.0 297.1 ..
United Kingdom 312.7 336.4 344.6 362.3 363.6 366.9 .. .. .. ..
United States 734.9 789.1 832.8 898.9 941.8 960.3 993.8 992.2 1010.9 1009.9

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

Year

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012
Country

 

 

 

 

 

 

 

 

 

 
Australia 8.3 8.6 8.5 8.5 8.5 8.8 9.1 9.0 9.2 9.4
Canada 9.5 9.6 9.6 9.7 9.8 10.0 11.1 11.1 10.9 (E) 10.9
France 10.8 10.9 10.9 10.9 10.8 (B) 10.9 11.6 11.6 11.5 11.6
Germany 10.9 10.7 10.8 10.6 10.5 10.7 11.8 11.6 11.2 11.3
New Zealand 7.8 (D) 8.0 (D) 8.3 (D) 8.7 (D) 8.4 (D) 9.3 (D) 9.8 (D) 10.0 (D) 10.0 (D) ..
United Kingdom 7.8 7.9 8.1 8.3 8.4 8.8 9.7 9.4 9.2 9.3
United States 15.1 15.2 15.2 15.3 15.6 16.1 17.1 17.0 17.0 16.9

Legend
B: Break
D: Difference in methodology
E: Estimated value

Sources: OECD Health Data 2014—Version September 2014

(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.

Drug Utilisation Trends

Anatomical Therapeutic Chemical (ATC) classification index with Defined Daily Doses (DDDs) 2014 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 2010, 2011 and 2012 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)

ATC Group 2010 2011 2012
(A) Alimentary Tract 28,953,537 28,759,545 29,185,246
(B) Blood and blood forming 8,966,904 9,017,907 9,093,482
(C) Cardiovascular system 69,548,351 71,098,590 71,104,881
(D) Dermatologicals 3,046,579 3,102,545 3,180,664
(G) Genitourinary system 3,018,712 3,055,906 3,184,425
(H) Hormonal preparations 3,030,020 3,109,963 3,220,223
(J) Antiinfectives 13,610,925 14,096,061 13,824,509
(L) Antineoplastic 2,283,945 2,401,958 2,719,753
(M) Musculo-skeletal 9,049,631 8,876,468 8,649,091
(N) Nervous system 41,134,894 43,165,597 44,781,092
(P) Antiparasitic products 619,916 663,096 658,725
(R) Respiratory system 10,931,315 11,230,513 11,535,338
(S) Sensory Organs 8,831,644 8,845,188 8,883,646
(V) Various 628,009 614,979 631,978
Other 234,263 216,324 174,482
Total 203,888,645 208,254,640 210,827,535

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

ATC Group 2010 2011 2012**
(A) Alimentary Tract 5,451,135 6,815,889 6,383,755
(B) Blood and blood forming 800,750 801,206 753,255
(C) Cardiovascular system 12,764,846 12,527,227 14,474,629
(D) Dermatologicals 3,091,722 3,111,775 1,296,434
(G) Genitourinary system 7,242,967 7,241,442 2,806,262
(H) Hormonal preparations 1,674,232 1,713,998 1,897,356
(J) Antiinfectives 15,271,945 15,836,654 13,281,511
(L) Antineoplastic 134,174 149,970 51,355
(M) Musculo-skeletal 3,090,936 3,114,591 2,894,706
(N) Nervous system 12,186,635 12,837,299 10,480,918
(P) Antiparasitic products 672,418 690,243 518,950
(R) Respiratory system 2,650,191 2,595,802 1,079,616
(S) Sensory Organs 2,295,925 2,159,266 1,654,461
(V) Various 21,220 26,031 2,827
Other 232,207 245,692 36,573
Total 67,581,303 69,867,085 57,612,608

** Non-subsidised prescriptions in 2012 exclude private prescriptions due to incomplete private prescriptions data.

Estimated changes from 2002 to 2012 in the number of prescriptions dispensed under the PBS (concession and general), RPBS, under co-payment and private categories, are presented in Figure C.  Note that full year of private prescriptions data are not available in 2012 therefore are omitted.

Figure C: Number of prescriptions by type of service

Figure C: Number of prescriptions by type of service

Most commonly used drugs in the Australian community for 2012

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 components, as well as total community use (excluding private usage). Changes and alterations from the previous years are also shown.

Table D: Top 10 drugs by defined daily dose/thousand population/day, 2012 (including the contribution of constituents of combination products)

Drug PBS/RPBS Under co-payment Total
ATORVASTATIN 73.21 0.06 73.27
PERINDOPRIL 31.80 12.55 44.36
IRBESARTAN 30.79 11.76 42.55
ROSUVASTATIN 40.89 0.07 40.96
RAMIPRIL 24.42 9.45 33.88
CANDESARTAN 28.20 5.43 33.63
PARACETAMOL 31.21 2.28 33.48
AMLODIPINE 26.20 5.76 31.96
COLCHICINE 17.96 8.60 26.55
ESOMEPRAZOLE 22.95 2.93 25.88

Changes from 2011:

UP: Perinopril (3 Arrow 2)
Colchicine (Unranked Arrow 9)
DOWN: Irbestatin (2 Arrow 3)
Simvastatin (9 Arrow 13)

The top 10 drugs dispensed in the Australian community (excluding private prescriptions) in 2012, ranked by prescription count, are shown in table E. Table F ranks the 2012 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, 2012

Drug PBS/RPBS Under co-payment Total
ATORVASTATIN 10,465,244 69,473 10,534,717
ROSUVASTATIN 7,551,663 8,798 7,560,461
ESOMEPRAZOLE 6,330,053 289,335 6,619,388
PARACETAMOL 5,678,060 92,752 5,770,812
PERINDOPRIL 3,945,729 364,452 4,310,181
PANTOPRAZOLE 3,922,579 233,883 4,156,462
METFORMIN HYDROCHLORIDE 3,493,052 293,757 3,786,809
SIMVASTATIN 3,477,709 90,185 3,567,894
CEFALEXIN 2,762,675 752,690 3,515,365
IRBESARTAN 3,092,970 260,159 3,353,129

Changes from 2011:

UP: Rosuvastatin (3 Arrow 2)
Metformin Hydrochloride  (9 Arrow 7)
DOWN: Esomeprazole (2 Arrow 3)
Amxycillin (4 Arrow 12)
IN: Simvastatin (12 Arrow 8)

Table F: Top 10 PBS/RPBS drugs by total cost to Australia, 2012

Drug DDD/1000/Day Scripts Total Cost
ATORVASTATIN 73.21 10,465,244 652,463,282
ROSUVASTATIN 40.89 7,551,663 467,763,297
RANIBIZUMAB 185,783 398,231,006
ESOMEPRAZOLE 22.95 6,330,053 239,376,101
SALMETEROL and FLUTICASONE 3,199,544 227,590,831
ADALIMUMAB 0.42 125,879 226,270,210
OLANZAPINE 3.11 987,037 158,069,700
TIOTROPIUM BROMIDE 6.92 1,910,380 143,958,981
ETANERCEPT 0.27 79,048 140,425,755
RITUXIMAB 46,008 139,649,353

Changes from 2011:

UP: Olanzaopine (8 Arrow 7)
Tiotropium Bromide (Unranked  Arrow 8)
DOWN: Clopidogrel (7 Arrow 11)
Simvastatin (9 Arrow Unranked)

Figure D shows the top 10 subsidised drugs dispensed in 2012.

Figure D: Top 10 subsidised drugs dispensed in 2012

Figure D: Top 10 subsidised drugs dispensed in 2012

Figure E represents the top 10 under co-payment drugs dispensed in 2012.

Figure E: Top 10 under co-payment drugs dispensed in 2012

Figure E: Top 10 under co-payment drugs dispensed in 2012

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 2012. Table H ranks the 2012 top 10 drugs prescribed by total cost.

Table G: Nurse Practitioner—Top 10 PBS/RPBS drugs by prescription counts,  2012

Drug PBS/RPBS  Prescriptions
ATORVASTATIN 2,988
PARACETAMOL 2,539
CEFALEXIN 2,329
OXYCODONE 2,008
ESOMEPRAZOLE 1,848
ROSUVASTATIN 1,693
CODEINE with PARACETAMOL 1,472
AMOXYCILLIN with CLAVULANIC ACID 1,462
AMOXYCILLIN 1,453
PERINDOPRIL 1,408

Table H: Nurse Practitioner—Top 10 PBS/RPBS drugs prescribed by total cost, 2012

Drug Total Cost ($)
ATORVASTATIN 184,185
POSACONAZOLE 139,487
PANCREATIC EXTRACT 118,710
INSULIN GLARGINE 107,964
ROSUVASTATIN 105,299
RISPERIDONE 104,704
SALMETEROL and FLUTICASONE 96,259
OLANZAPINE 93,965
EXENATIDE 82,404
ESOMEPRAZOLE 72,886

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 2012. Table J ranks the 2012 top 10 drugs prescribed by total cost.

Table I: Optometrist—Top 10 PBS/RPBS drugs by prescription counts, 2012

Drug PBS/RPBS Prescriptions
LATANOPROST 11,242
FLUOROMETHOLONE 8,277
POLYETHYLENE GLYCOL 400 with PROPYLENE GLYCOL 7,958
CHLORAMPHENICOL 7,230
CARMELLOSE SODIUM 3,593
TIMOLOL with LATANOPROST 3,087
HYPROMELLOSE with CARBOMER 980 2,667
HYPROMELLOSE 2,639
PARAFFIN 2,222
BIMATOPROST 1,919

Table J: Optometrist—Top 10 PBS/RPBS drugs prescribed by total cost, 2012

Drug Total Cost
($)
LATANOPROST 445,422
TIMOLOL with LATANOPROST 135,536
POLYETHYLENE GLYCOL 400 with PROPYLENE GLYCOL 95,241
FLUOROMETHOLONE 88,259
BIMATOPROST 80,973
CHLORAMPHENICOL 75,818
TRAVOPROST 63,844
CARMELLOSE SODIUM 55,014
BIMATOPROST with TIMOLOL MALEATE 47,482
PARAFFIN 45,120

Tables in the Australian Statistics on Medicines

The data are presented in two major tables.

Table 1: 2012 Under Copayment and PBS/RPBS Prescription Numbers for PBS Listed Drugs

  • Table 1 provides an estimate of the 2012 community prescription numbers for both subsidised and under-copayment prescriptions.  The defined daily dose (DDD), where available, is also included for the drugs covered in the report.
  • Table 1 (Excel 292 KB)

Table 2: Community Prescription Drug use, in DDD/1000/Day, for 2010 to 2012

  • Table 2 includes community prescription drug use, in DDDs/1000 population/day, for the years 2010, 2011 and 2012.   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.  Estimates of private prescriptions data are available up to 2011.
  • Table 2 (Excel 242 KB)

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) 2014 is used in statistics published in this edition (refer to WHO collaborating Centre for Drug Statistics Methodology, ATC classification index with DDDs 2014).

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.

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), private prescriptions data after 2011, 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

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

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)

ATC & DDD Additions and Alterations (2014)

Alterations in ATC classification

Previous ATC code ATC level name New ATC code
B02BC10 fibrinogen, human B02BC30
B03AC01 ferric oxide polymaltose complexes B03AC
B03AC02 saccharated iron oxide B03AC2)
B03AC03 iron-sorbitol-citric acid complex B03AC
B03AC05 ferric sorbitol gluconic acid complex B03AC
B03AC06 ferric oxide dextran complexes B03AC
B03AC07 ferric sodium gluconate complex B03AC 
B06AA11 bromelains D03BA03
R03AK03 fenoterol and ipratropium bromide  R03AL01
R03AK04  salbutamol and ipratropium bromide R03AL02
R03AK07  formoterol and beclometasone R03AK08
R03AK07  formoterol and mometasone R03AK09

Alterations in ATC level classification

ATC code Previous ATC level name New ATC level name or new ATC level
A10AD Insulins and analogues for injection, intermediate-acting combined with fast-acting Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting
B03AC Iron trivalent, parenteral preparations Iron, parenteral preparations
G02A Oxytocics Uterotonics
G02AX Other oxytocics Other uterotonics
G03XB Antiprogestogens Progesterone receptor modulators
H01AB01 thyrotropin thyrotropin alfa
N02BG10 nabiximols Cannabinoids
R03AK Adrenergics and other drugs for obstructive airway diseases Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
R03AK04 salbutamol and other drugs for obstructive airway diseases salbutamol and sodium cromoglicate
R03AK05 reproterol and other drugs for obstructive airway diseases reproterol and sodium cromoglicate
R03AK06 salmeterol and other drugs for obstructive airway diseases salmeterol and fluticasone
R03AK07 formoterol and other drugs for obstructive airway diseases formoterol and budesonide

Allocation of new ATC codes

ATC code ATC level name
V10XX03 radium (223Ra) dichloride
V09IA09 technetium (99mTc) tilmanocept
V09IA08 technetium (99mTc) etarfolatide
V03AE06 Colestilan
V03AE05 sucroferric oxyhydroxide
S01XA22 Ocriplasmin
S01XA21 Mercaptamine
R06AX32 Sequifenadine
R05CA13 Cineole
R03AL04 indacaterol and glycopyrronium bromide
R03AL03 vilanterol and umeclidinium bromide
R03AL 1 Adrenergics in combination with anticholinergics
R03AK11 formoterol and fluticasone
R03AK10 vilanterol and fluticasone furoate
R03AC19 Olodaterol
N07XX10 Laquinimod
N07XX09 dimethyl fumarate
N07BB05 Nalmefene
N06DA05 Ipidacrine
N06BX22 Phenibut
N06BX21 Mebicar
N06AX26 Vortioxetine
M05BX53 strontium ranelate and colecalciferol
M02AX06 Tolperisone
L04AX06 Pomalidomide
L04AA32 Apremilast
L04AA31 Teriflunomide
L03AX18 Cridanimod
L01XX45 Carfilzomib
L01XX44 aflibercept
L01XE25 trametinib
L01XE24 ponatinib
L01XE23 dabrafenib
L01XC15 obinutuzumab
L01XC14 trastuzumab emtansine
L01CA06 vintafolide
J07BA03 encephalitis, Japanese, live attenuated
J05AX12 dolutegravir
J05AR11 lamivudine, tenofovir disoproxil and efavirenz
J04AK06 delamanid
J04AK05 bedaquiline
J01RA05 levofloxacin and ornidazole
G03XC05 ospemifene
G03XB02 ulipristal
G03FB12 nomegestrol and estrogen
G03AA16 dienogest and ethinylestradiol
D11AX21 brimonidine
D02BB02 afamelanotide
C10BX05 rosuvastatin and acetylsalisylic acid
C10BA06 rosuvastatin and ezetimibe
C09DB07 candesartan and amlodipine
C09BX01 perindopril, amlodipine and indapamide
C09BX ACE inhibitors, other combinations
C08GA02 amlodipine and diuretics
C02KX04 macitentan
C01EB22 meldonium
C01DX21 serelaxin
C01BC09 ethacizine
A16AX10 eliglustat
A12AA13 calcium citrate
A10BX12 empagliflozin
A10BX11 canagliflozin
A10BX10 lixisenatide
A10BH06 gemigliptin
A10BD15 metformin and dapagliflozin
A10BD14 metformin and repaglinide
A10AE06 insulin degludec
A10AD06 insulin degludec and insulin aspart
A08AA11 lorcaserin
A06AH03 naloxegol

1  Split of ATC 4th level R03AK, separate 4th level for combinations with anticholinergics.

Allocation of new DDDs

ATC code ATC level name

New DDD
A10BH06 gemigliptin 50 mg O
A10BX09 dapagliflozin 10 mg O
A11CC05 colecalciferol 20 mcg O
G03XB02 ulipristal 5 mg O
G04BD12 mirabegron 50 mg O
H01AB01 thyrotropin alfa 0.9 mg P
H01CB05 pasireotide 1.2 mg P
J01DI02 ceftaroline fosamil 1.2 g P
J04AK05 bedaquiline 86 mg O
L04AA31 teriflunomide 14 mg O
N03AX22 perampanel 8 mg O
N07XX08 tafamidis 20 mg O
R03BB05 aclidinium bromide  0.644 mg Inhal powder/polvo inhal
R03BB06 glycopyrronium bromide  44 mcg Inhal powder/polvo inhal
R05CB16 mannitol 0.8 g Inhal powder/polvo inhal
R07AX02 ivacaftor 0.3 g O

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.