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Monday, 22 October 2018
Page: 10542

Health Care

Dear Chair

I refer to your letter of 25 June 2018 concerning the Standing Committee on Petitions - medication side-effects - EN0607.

It is important to note that, while safety is of paramount importance, the Australian Government is also committed to ensuring that the community has access, within a reasonable time, to therapeutic advances.

The Therapeutic Goods Administration (TGA) applies a risk management approach designed to ensure therapeutic goods, including medicines, supplied in Australia meet acceptable standards of quality, safety and efficacy. In particular, the TGA employs scientific and clinical expertise to ensure that the benefits to consumers outweigh the risks associated with use of a medicine. Once a medicine is approved, the TGA continues to monitor the product in the market through therapeutic product vigilance activities. The main product vigilance tools used by the TGA are adverse event reports, Risk Management Plans and Periodic Safety Update Reports.

The maintenance and improvement of health and safety is a shared responsibility. However, 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.

Under-reporting of adverse events is recognised as a global issue. The number of adverse events reported for a given medicine is clearly important information, as is the volumes being used, but is not the sole source of information used by regulators to make judgements on the benefit-risk profile of a medicine. As well as the number of reports received, regulators also take into account the seriousness of the issues reported as well as information from overseas jurisdictions in order to build a more complete picture.

In recent years, the TGA has undertaken various projects and activities to promote adverse event reporting and improve the use of data to maintain medicine safety. These activities have included increased international collaboration related to adverse event reporting, including involvement in the International Coalition of Medicines Regulatory Authorities working group, and projects completed in response to the Review of Medicine and Medical Device Regulation (MMDR).

Under MMDR, the TGA has:

Upgraded its adverse event management system, which has new on-line reporting forms to better capture essential adverse event data and improved analytics to better assess reporting data, with further enhancements in the process of being completed.

Commenced investigating the use of large health datasets such as Pharmaceutical Benefits Scheme, Medicare Benefits Scheme and state and territory hospital discharge data in safety signal investigation to ensure they have access to denominator data on medicine usage to investigate adverse events.

Launched the Phannacovigilance Inspection Program, an initiative to help medicine sponsors to meet their pharmacovigilance obligations.

Initiated the Black Triangle Scheme, which provides a simple means for doctors and consumers to identify certain types of new prescription medicines, or those being used in significantly different ways and encourages reporting of adverse events associated with them. The TGA has recently completed promotion of this through social media channels to increase both health care professional and consumer awareness.

Implemented a new format for medicine Product Information to make clinical information, including information about potential adverse events, easier to find for doctors and to align with other international regulators.

All required information required relating to an adverse event reporting is currently requested in the various reporting mediums, including the blue card. Where an adverse event report includes a serious adverse event then information is sought from the reporter by the TGA to be able to assess whether there is a possible causal link between the medicine and the adverse event. While the TGA has no ability to require the information to be provided from reporters other than sponsors, every effort is made to obtain this information and have this information included in the report.

While it is generally acknowledged that adverse events are under-reported around the world and the TGA is committed to improving in this area, it is important to note that adverse event monitoring is just one of the therapeutic product vigilance tools that the regulator uses.

My Department recognises there are risks associated with some medicines; however, there is no Australian requirement to include warning statements about side-effects on prescription medicine labels.

Warning statements for prescription medicines can be lengthy and complex, and for high risk medicines, there can be many warnings. Information included on a prescription medicine label is to accurately identify and store the medicine to assist in its safe use. Selection of the medicine for a patient, and consideration of contraindications, occurs in discussion with the prescribing doctor. It is important that warnings and potential issues are discussed with the patient at the time of the doctor prescribing the medicine.

To assist doctors in prescribing, all prescription medicines must have a Product Information document, which describes known side-effects and contraindications. To assist patients, a simplified version, the Consumer Medicine Information, is also available for dispensing pharmacists and should be provided to consumers in all community pharmacies. Both documents are also available on the TGA website.Lastly, my Department understands the importance of supporting individuals to appropriately manage their medications, this includes through a number of medication management programs under which community pharmacists and accredited pharmacists are funded to support the quality use of medicines by patients with a view to reducing adverse medicine events and associated hospital admissions or medical presentations. These medication management programs are Home Medicines Review, MedsCheck, Diabetes MedsCheck, Residential Medication Management Review and Quality Use of Medicines (in residential aged care facilities).

The Home Medicines Review (HMR) program provides a home-based review of a patient's medications by an accredited pharmacist. The HMR service is provided to an eligible patient, on referral from that patient's GP, and provides information to the patient and to support a subsequent medication management plan prepared by the referring GP.

The MedsCheck program provides an in-pharmacy service that includes a review of a patient's medicines, focusing on education and self-management and aims to identify problems that the patient may be experiencing with their medicines. The service also aims to educate patients about their medicines including how medicines affect medical conditions, and improve the effective use and storage of medicines. Similarly, a Diabetes MedsCheck is a review of medications with a focus on the patient's type 2 diabetes medicines management.

The Residential Medication Management Review program provides services to permanent residents of Australian Government funded aged care facilities when requested by a resident's GP. A comprehensive assessment is undertaken to identify, resolve and prevent medication-related problems. The Quality Use of Medicines (QUM) service is provided by a registered or accredited pharmacist and focuses on improving practices and procedures as they relate to the quality use of medicines in a residential care facility.

The QUM strategy is one of the central objectives of the National Medicines Policy. QUM considers that all medicines be used judiciously, appropriately, safely and efficaciously. QUM relies on the wise selection of management options, choosing a suitable medicine if a medicine is considered necessary and using medicines safely and effectively to achieve the best possible results. The goal of the National Strategy for QUM is to make best possible use of medicines to improve health outcomes for all Australians.

The Australian Government funds NPS MedicineWise, an independent, not-for-profit organisation that provides evidence-based information, support tools and education services to health professionals and consumers to improve quality use of medicines in Australia. NPS MedicineWise activities to support the safe use of medicines include targeted activities to improve pharmacovigilance and reporting of adverse events:

Continuing Professional Development courses for healthcare providers to update prescribers and health professionals on what constitutes a reportable adverse event with medicines, vaccines and medical devices, what steps to take to report to the TGA including blue cards, and the importance of reporting. Health professionals who complete the modules are eligible for continuing professional development points from the relevant accrediting health professional bodies.

Consumer reporting through the Adverse Medicines Events Line. The Line is operated by clinical pharmacists and provides consumers with an avenue for reporting and discussing adverse experiences associated with medicines.

Product information through Medicine Finder and MedicineWise App assisting consumers understand medicines, Consumer Medicine Information and manage their medicines.

Choosing Wisely Initiative which encourages more effective communication between consumers and healthcare providers.

I hope this response is helpful and outlines the Government's active role in balancing medicine safety and timely patient access.

Yours sincerely

from the Minister for Health, Mr Hunt (Petition No. EN0607)