• Home/
  • Statistics/
  • Asm/
  • Asm 2013

Australian Statistics on Medicines 2013

Page last updated: 7 March 2016

Acknowledgments

Prepared by Vanna Mabbott and Paul Storey 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, Therapeutic Goods Administration.
  • David Nott and Shannon Barbaro, Pharmaceutical Access, Department of Health.
  • The World Health Organization Collaborating Centre for Drug Statistics Methodology.

Australian Statistics on Medicine 2013

Copyright Statements:

Internet sites

© Commonwealth of Australia 2015
This work is copyright. You may download, display, print and reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given the specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the Online, Services and External Relations Branch, Department of Health, GPO Box 9848, Canberra ACT 2601, or via e-mail to copyright@health.gov.au.

Contents

Introduction

The data contained in the 2013 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 2013 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 2011, 2012 and 2013. 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 and 2013 data reported in this edition.

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 2013, general patients paid the cost of a prescription up to a maximum of $36.10. Pensioner and concession patients paid $5.90 per prescription.

In addition, there is a Safety Net Scheme to protect people with high medication needs. In 2013, once general patients and/or their immediate family incurred $1,390.60 of PBS expenditure (indexed), PBS/RPBS prescriptions for the remainder of the calendar year cost only $5.90 per prescription. Once pensioners and other concession card holders reached the concession safety net threshold of $354 expenditure (indexed), they received all remaining prescriptions in 2013 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 2013, under co-payment general prescriptions represented around 24% of community prescriptions (excluding private 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 adults2.

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 necessary2.

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 for 2012 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

From 1989 to 2012, DUSC 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.

The pharmacies in the survey were selected to be representative of the population of operational pharmacies with regard to PBS dispensing volume and geographical location, and were 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 were stratified into the same four equal dispensing volume ranges based on their annual average PBS dispensing from the previous year. A weighting factor was 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 were calculated by multiplying the survey estimate by the weighting factor, which was assumed to apply equally to the subsidised and nonsubsidised prescription volumes.

Estimates of private prescription volumes are not included in the 2012 and 2013 data throughout this edition. The Pharmacy Guild Survey data, and therefore private prescription volume estimates, ceased at the end of 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.

Adverse Event Reporting in Australia in 2013

The TGA's reporting system for adverse events began in the late 1960s with the computerised database dating back to the early 1970s.  By the end of 2013 there were approximately 278,000 reports of suspected adverse events in the database.

Figure A: Origin of adverse event reports received by the TGA (2007-2013)

Figure A: Origin of adverse event reports received by the TGA (2007-2013)

In 2013 the TGA received approximately 17,500 reports of adverse events. As shown in Figure 1, the majority of reports made in 2013 were by sponsors. The number of reports made by sponsors has steadily increased over the past five years, more than doubling since 2009. Approximately 55% (9563) of adverse event reports received by the TGA in 2013 were from sponsors, 10% (1794) from hospitals and hospital pharmacists, 4% (733) from general practitioners (GPs), 17% (3011) from State and Territory Health Departments (Adverse Events Following Immunisation), 7% (1268) from community pharmacists and 3% (574) from consumers.

In each group, the number of reports received increased in 2013 from the 2012 levels, with State and Territory Health Departments registering the biggest proportional increase (up over 60% from 1857 reports in 2012 to 3011 reports in 2013). However, this increase followed two years of decline in 2011 and 2012.

While health professionals are encouraged to report suspected adverse events directly to the TGA although they can also report directly to the sponsor or manufacturer.

Processing and use of adverse event reports

The OPR assessed adverse event reports submitted to the TGA by checking 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 OPR 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 OPR staff 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.

Database of adverse events notifications

Information in the publicly searchable Database of Adverse Event Notifications (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, which was launched in 2012, 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 and vaccines available in Australia, including prescription medicines, 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 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.

For further information about reporting suspected adverse events, visit the TGA website (click on 'Report a Problem').

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 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 during 2013:

  • Progressive multifocal leukoencephalopathy - a rare but serious disease
  • Thyroxine (Eutroxsig and Oroxine) and fractures
  • Oral bowel cleansing products - serious electrolyte disturbances
  • Montelukast - neuropsychiatric risks
  • Use of 2013 seasonal influenza vaccines in children
  • Denosumab and severe hypocalcaemia
  • Anticholinergics and cognitive impairment
  • System for Australian Recall Actions
  • Changes to cough and cold medicines for use in children
  • Update - Progressive multifocal leukoencephalopathy (PML)
  • Mitigating risks of dabigatran: right patient, right dose and careful clinical monitoring
  • New dabigatran contraindication
  • Vancomycin and nephrotoxicity
  • Dapagliflozin - new chemical entity
  • Dexmedetomidine hydrochloride and cardiovascular events
  • Bevacizumab and necrotising fasciitis
  • Atomoxetine and suicidality in children and adolescents
  • Rotavirus vaccination and the risk of intussusception
  • Drug-induced liver injury
  • Pioglitazone risk-benefit review
  • 5-alpha reductase inhibitors and risk of high-grade prostate cancer
  • Duloxetine and serotonin syndrome
  • Minocycline and intracranial hypertension

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 to continually monitor and evaluate the safety and efficacy (performance) profile of therapeutic goods and to manage any risks associated with individual products over their life cycle. The TGA's therapeutic product vigilance framework is available on the TGA website atTherapeutic product vigilance.

The maintenance and improvement of health and safety is a shared responsibility. In addition to government and industry, health professionals, consumers and their respective associations play an important role in reporting 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 (the Act) 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 consumers and health professionals. The TGA is committed to advancing public health through market authorisation of beneficial, innovative therapeutic goods 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 the 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 consumers and health professionals. To achieve this, the TGA publishes Australian Public Assessment Reports (AusPARs) about recently registered prescription medicines on the TGA website. AusPARs outline 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, as well as safety alerts, Early Warning System monitoring communications and Medicines Safety Update, which provide information and recommendations about therapeutic good.

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 commonly 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 2013 to December 2013

Drug Name Total cost ($Aus) Pack Numbers
ABACAVIR $1,464,739 5,400
ABACAVIR + LAMIVUDINE $18,212,389 35,099
ABACAVIR + LAMIVUDINE + ZIDOVUDINE $991,587 1,228
ABATACEPT $5,648,742 10,830
ADALIMUMAB $2,679,135 1,604
ADEFOVIR DIPIVOXIL $2,860,515 4,577
AMBRISENTAN $10,264,085 2,879
APOMORPHINE $3,509,734 28,674
ATAZANAVIR $17,754,820 32,452
AZACITIDINE $20,361,195 36,935
AZITHROMYCIN $57,830 1,006
BACLOFEN $1,218,674 8,214
BOCEPREVIR $14,009,812 3,574
BOSENTAN $31,814,959 8,825
CINACALCET $5,561,391 11,841
CLARITHROMYCIN $66,526 1,488
CLOZAPINE $29,932,754 171,313
CYCLOSPORIN $8,724,758 105,531
DARBEPOETIN ALFA $54,235,290 93,655
DARUNAVIR $14,110,974 15,642
DEFERASIROX $15,356,640 18,066
DEFERIPRONE $545,250 1,222
DESFERRIOXAMINE $637,981 14,075
DIDANOSINE $237,596 834
DORNASE ALFA $12,428,617 10,533
DOXORUBICIN HYDROCHLORIDE-PEGYLATED LIPOSOMAL $48,593 78
EFAVIRENZ $2,488,561 9,200
ELTROMBOPAG $2,410,401 1,082
EMTRICITABINE $214,038 759
EMTRICITABINE + RILPIVIRINE + TENOFOVIR $14,726,143 14,205
ENFUVIRTIDE $303,181 137
ENTECAVIR $13,937,691 34,011
EPOETIN ALFA $15,959,817 24,477
EPOETIN BETA $5,485,368 8,595
EPOETIN LAMBDA $3,947,105 6,789
EPOPROSTENOL $2,797,219 35,225
ETANERCEPT $2,243,526 2,250
ETRAVIRINE $4,276,930 6,937
EVEROLIMUS $6,385,028 8,963
FILGRASTIM $13,011,447 8,932
FOSAMPRENAVIR $406,920 1,085
GANCICLOVIR $82,659 295
IBANDRONIC ACID $135,861 398
ILOPROST $2,019,874 1,828
INDINAVIR $61,275 135
INFLIXIMAB $59,563,567 78,365
INTERFERON ALFA-2A $14,006 470
INTERFERON ALFA-2B $356,348 983
INTERFERON GAMMA-1B $415,750 305
LAMIVUDINE $2,905,055 17,705
LAMIVUDINE + ZIDOVUDINE $2,523,134 4,914
LANREOTIDE $7,666,425 4,110
LANTHANUM $2,491,943 6,676
LENALIDOMIDE $38,059,658 5,928
LENOGRASTIM $197,134 204
LEVODOPA + CARBIDOPA ANHYDROUS $235,046 163
LOPINAVIR + RITONAVIR $8,560,148 13,000
MANNITOL $410,998 947
MARAVIROC $2,171,434 2,370
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA $9,966,661 16,064
MYCOPHENOLATE $18,367,407 100,772
NATALIZUMAB $33,208,552 16,291
NEVIRAPINE $7,224,232 31,725
OCTREOTIDE $14,717,641 11,170
OMALIZUMAB $3,593,068 8,306
PAMIDRONATE DISODIUM $694,943 3,995
PEGFILGRASTIM $51,607,248 26,811
PEGINTERFERON ALFA-2A $1,585,486 1,182
PEGINTERFERON ALFA-2A (&) RIBAVIRIN $26,678,903 16,379
PEGINTERFERON ALFA-2B (&) RIBAVIRIN $13,245,587 7,009
RALTEGRAVIR $24,577,251 36,928
RIFABUTIN $34,097 231
RILPIVIRINE $189,291 697
RITONAVIR $2,196,459 53,587
RITUXIMAB $7,437,329 3,270
ROMIPLOSTIM $7,044,488 5,097
SAQUINAVIR $278,311 551
SEVELAMER $2,876,191 9,278
SILDENAFIL $1,810,369 1,936
SIROLIMUS $2,445,156 2,953
STAVUDINE $128,866 307
TACROLIMUS $27,080,585 83,336
TADALAFIL $545,471 629
TELAPREVIR $16,452,054 6,640
TELBIVUDINE $7,526 30
TENOFOVIR $14,827,336 30,692
TENOFOVIR + EMTRICITABINE $45,615,392 59,620
TENOFOVIR + EMTRICITABINE + EFAVIRENZ $43,695,361 42,149
THALIDOMIDE $5,711,745 10,558
TIPRANAVIR $148,869 139
TOCILIZUMAB $15,335,124 29,897
TRASTUZUMAB $137,636 199
VALACICLOVIR $194,544 463
VALGANCICLOVIR $18,004,123 8,438
ZIDOVUDINE $230,227 1,353
ZOLEDRONIC ACID $10,314,450 22,921
Grand Total $917,406,255 1,578,623

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 at: http://www.health.gov.au/internet/main/publishing.nsf/Content/health-pbs-indigenous

Expenditure

In 2013, 173 remote area Aboriginal Health Services (AHS) were approved to participate in the Remote Area Aboriginal Health Services (RAAHS) Programme and 156 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 2013 were from remote locations in Northern Territory, Queensland, Western Australia, South Australia, New South Wales and Tasmania.  RAAHS Programme expenditure on PBS medicines in 2013 was $42.7 million.

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 2014).

Listed below are the prescription counts for 2011, 2012 and 2013 by ATC anatomical main group. The data from the two sources are enumerated separately. Table B (i) shows subsidised prescriptions (PBS/RPBS) and Table B (ii) shows the estimate of nonsubsidised prescriptions (Survey).

Tables B: Prescription numbers by ATC groups

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

ATC Group 2011 2012 2013
(A) Alimentary Tract 28,759,546 29,185,683 30,245,667
(B) Blood and blood forming 9,017,908 9,093,594 9,171,651
(C) Cardiovascular system 71,098,592 71,106,134 70,276,382
(D) Dermatologicals 3,102,546 3,180,743 3,159,665
(G) Genitourinary system 3,055,906 3,184,460 3,368,904
(H) Hormonal preparations 3,109,963 3,220,268 3,299,652
(J) Antiinfectives 14,096,064 13,824,691 13,420,485
(L) Antineoplastic 2,401,958 2,719,818 2,921,524
(M) Musculo-skeletal 8,876,468 8,649,252 8,440,179
(N) Nervous system 43,165,598 44,781,627 47,354,746
(P) Antiparasitic products 663,096 658,736 610,700
(R) Respiratory system 11,230,514 11,535,520 11,649,096
(S) Sensory Organs 8,845,188 8,883,844 8,882,737
(V) Various 614,979 631,981 611,573
Other 216,324 174,483 170,662
Total 208,254,650 210,830,834 213,583,623

Table B (ii): Estimated non-subsidised prescriptions

ATC Group 2011 2012** 2013**
(A) Alimentary Tract 6,815,889 6,383,965 7,624,960
(B) Blood and blood forming 801,206 753,275 994,138
(C) Cardiovascular system 12,527,227 14,475,175 18,145,961
(D) Dermatologicals 3,111,775 1,296,486 1,407,136
(G) Genitourinary system 7,241,442 2,806,368 3,175,609
(H) Hormonal preparations 1,713,998 1,897,428 2,213,513
(J) Antiinfectives 15,836,654 13,281,940 13,937,431
(L) Antineoplastic 149,970 51,358 67,896
(M) Musculo-skeletal 3,114,591 2,894,791 3,360,016
(N) Nervous system 12,837,299 10,481,319 12,875,010
(P) Antiparasitic products 690,243 518,983 620,059
(R) Respiratory system 2,595,802 1,079,643 1,173,793
(S) Sensory Organs 2,159,266 1,654,539 1,792,520
(V) Various 26,031 2,827 5,032
Other 245,692 36,574 49,339
Total 69,867,085 57,614,671 67,442,413

** Non-subsidised prescriptions in 2012 and 2013 exclude private prescriptions due to data no longer being captured.  In addition, under copayment component of the non-subsidised  prescriptions is based on a survey data from 01 January 2012 to 30 April 2012 and from 01 May 2012 onwards data is based on prescriptions processed by the Department of  Human Services.

Estimated changes from 2004 to 2013 in the number of prescriptions dispensed under the PBS (concession and general), RPBS, under co-payment and private categories, are presented in Figure B.  Note that private prescriptions data are not available from 2012.

Figure B: Number of prescriptions by type of service

Figure B: Number of prescriptions by type of service

Most commonly used drugs in the Australian community for 2013

Table C 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 C: Top 10 drugs by defined daily dose/thousand population/day, 2013 (including the contribution of constituents of combination products)

Drug PBS/RPBS Under co-payment Total
ATORVASTATIN 68.42 1.49 69.91
PERINDOPRIL 32.64 14.47 47.11
ROSUVASTATIN 43.17 0.92 44.09
IRBESARTAN 29.39 12.53 41.93
AMLODIPINE 27.62 8.27 35.89
PARACETAMOL 33.24 2.57 35.82
CANDESARTAN 24.75 9.73 34.48
RAMIPRIL 23.18 10.34 33.52
COLCHICINE 17.96 10.43 28.39
TELMISARTAN 18.04 10.01 28.05

Changes from 2012:

UP: Rosuvastatin (4 Arrow 3)
Amlodipine (8 Arrow 5)
Paracetamol (7 Arrow 6)
Temisartan (unranked Arrow 10)
DOWN: Irbesartan (3  Arrow 4)
Ramipril (5  Arrow 8)
Candesartan (6  Arrow 7)

The top 10 drugs dispensed in the Australian community (excluding private prescriptions) in 2013, ranked by prescription count, are shown in table D. Table E ranks the 2013 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 D: Top 10 drugs by prescription counts, 2013

Drug PBS/RPBS Under co-payment Total
ATORVASTATIN 9,663,728 543,153 10,206,881
ROSUVASTATIN 7,798,503 517,336 8,315,839
ESOMEPRAZOLE 6,809,152 1,452,069 8,261,221
PARACETAMOL 6,171,295 387,097 6,558,392
PERINDOPRIL 3,969,794 1,962,122 5,931,916
AMOXYCILLIN 2,319,189 3,352,008 5,671,197
PANTOPRAZOLE 4,098,649 1,340,355 5,439,004
CEFALEXIN 2,785,925 2,633,479 5,419,404
METFORMIN HYDROCHLORIDE 3,548,730 1,478,602 5,027,332
AMOXYCILLIN with CLAVULANIC ACID 2,021,756 2,495,653 4,517,409

Changes from 2012:

UP: Amoxycillin (unranked  Arrow 6)
Cefalexin  (10  Arrow 8)
DOWN: Pantoprazole (6  Arrow 7)
Metformin Hydrochloride  (8 Arrow 9)
IN: Amoxicillin with Clavulanicacid (unranked  Arrow 10)

Table E: Top 10 PBS/RPBS drugs by total cost to Australia, 2013

Drug DDD/1000/Pop Scripts Total Cost
ATORVASTATIN 68.42 9,663,728 452,445,622
ROSUVASTATIN 43.17 7,798,503 391,415,746
ESOMEPRAZOLE 24.44 6,809,152 259,476,101
ADALIMUMAB 0.47 143,123 257,081,480
SALMETEROL and FLUTICASONE 3,199,870 228,577,647
RANIBIZUMAB 113,334 194,335,814
AFLIBERCEPT 96,237 163,669,291
OLANZAPINE 3.14 1,011,584 150,547,759
RITUXIMAB 43,467 150,190,886
ETANERCEPT 0.28 83,962 149,003,797

Changes from 2012:

UP: Esomeprazole (4  Arrow 3)
Adalimumab (6 Arrow 4)
Rituximab (10 Arrow 9)
DOWN: Ranibizumab (3 Arrow 6)
Olanzapine (7 Arrow 8)
IN: Aflibercept (unranked Arrow 7)

Figure C shows the top 10 subsidised drugs dispensed in 2013.

Figure C: Top 10 subsidised drugs dispensed in 2013

Figure C: Top 10 subsidised drugs dispensed in 2013

Figure D represents the top 10 under co-payment drugs dispensed in 2013.

Figure D: Top 10 under co-payment drugs dispensed in 2013

Figure D: Top 10 under co-payment drugs dispensed in 2013

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 F shows the top 10 PBS/RPBS drugs prescribed by nurse practitioners and dispensed in 2013. Table G ranks the 2013 top 10 drugs prescribed by total cost.

Table F: Nurse Practitioner—Top 10 PBS/RPBS drugs by prescription counts, 2013

Drug PBS/RPBS Prescriptions
PARACETAMOL 5,459
ATORVASTATIN 4,801
CEFALEXIN 3,386
ESOMEPRAZOLE 3,343
OXYCODONE 3,120
ROSUVASTATIN 2,769
PANTOPRAZOLE 2,691
PERINDOPRIL 2,470
CODEINE with PARACETAMOL 2,348
METFORMIN HYDROCHLORIDE 2,148

Table G: Nurse Practitioner—Top 10 PBS/RPBS drugs prescribed by total cost, 2013

Drug Total Cost ($)
ATORVASTATIN 217,770
INSULIN GLARGINE 192,615
PANCREATIC EXTRACT 188,868
OLANZAPINE 187,100
PALIPERIDONE 143,368
SALMETEROL and FLUTICASONE 141,075
ROSUVASTATIN 139,358
RISPERIDONE 132,328
ESOMEPRAZOLE 127,342
QUETIAPINE 118,034

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 H shows the top 10 PBS/RPBS drugs prescribed by optometrists and dispensed in 2013. Table I ranks the 2013 top 10 drugs prescribed by total cost.

Table H: Optometrist—Top 10 PBS/RPBS drugs by prescription counts, 2013

Drug PBS/RPBS Prescriptions
LATANOPROST 14,548
FLUOROMETHOLONE 9,695
POLYETHYLENE GLYCOL 400 with PROPYLENE GLYCOL 8,142
CHLORAMPHENICOL 7,412
TIMOLOL with LATANOPROST 4,085
CARMELLOSE SODIUM 3,477
HYPROMELLOSE 2,989
HYPROMELLOSE with CARBOMER 980 2,888
PARAFFIN 2,636
TRAVOPROST 2,443

Table I: Optometrist—Top 10 PBS/RPBS drugs prescribed by total cost, 2013

Drug Total Cost ($)
LATANOPROST 534,339
TIMOLOL with LATANOPROST 167,617
FLUOROMETHOLONE 104,409
TRAVOPROST 103,555
BIMATOPROST 100,505
POLYETHYLENE GLYCOL 400 with PROPYLENE GLYCOL 100,139
CHLORAMPHENICOL 79,167
TIMOLOL with TRAVOPROST 65,144
BIMATOPROST with TIMOLOL MALEATE 62,206
CARMELLOSE SODIUM 59,384

Tables in the Australian Statistics on Medicines

The data are presented in two major tables.

Table 1: 2013 Under Copayment and PBS/RPBS Prescription Numbers for PBS Listed Drugs

  • Table 1 provides an estimate of the 2013 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 2011 to 2013

  • Table 2 includes community prescription drug use, in DDDs/1000 population/day, for the years 2011, 2012 and 2013.   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 230 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) Nordic Council on Medicines. Nordic Statistics on Medicines 1987-1989. NLN publication number 3, Uppsala, Sweden, 1990.

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 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:
Paul Storey
Director
PBS Information Management Section
Department of Health
GPO Box 9848
CANBERRA ACT 2601.
e-mail: pbsstats@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
R03AK046 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.