Click on a link below to find out more about the BPR:
What is the Bosentan Patient Registry (BPR)?What is Pulmonary Arterial Hypertension?
Treatment for PAH: Bosentan
Who will be asked to join the BPR?
What information will be collected by the BPR?
Who has access to this information?
What if you decide to withdraw from the BPR?
Who manages the BPR?
What is the Bosentan Patient Registry (BPR)?
The Bosentan Patient Registry (BPR) is a new initiative established in association with the Pharmaceutical Benefits Scheme (PBS).
The BPR is a database that will collect and store information about the health of people who take bosentan, over a period of three years.
This information is intended to help further our knowledge about the health outcomes of Australian patients who take bosentan for the treatmeant of PAH. Your doctor can discuss this further with you.
return to topWhat is Pulmonary Arterial Hypertension?
Pulmonary Arterial Hypertension (PAH) is a complex health problem, where there is high blood pressure in the blood vessels between the heart and the lungs.
One of the problems found in PAH is an abnormally high amount of a hormone-like substance called endothelin, which plays a role in causing the high blood pressure in vessels between the heart and lungs.
return to topTreatment for PAH: Bosentan
Bosentan belongs to a class of medicines known as endothelin receptor antagonists.
Bosentan blocks the harmful effects of endothelin and helps to widen the affected vessels, relieving the high blood pressure and symptoms associated with PAH.
Bosentan is available on the Pharmaceutical Benefits Scheme (PBS) for the treatment of primary pulmonary hypertension, or pulmonary arterial hypertension secondary to scleroderma.
The PBS is a Commonwealth Government initiative, that subsidises the cost and provides access to standard of care medicines.
return to topWho will be asked to join the BPR?
All people who are eligible for bosentan will be invited to join the BPR.
Participation in the BPR is voluntary. If you choose not to take part in the BPR, it will not affect your access to bosentan or your routine treatment.
Before you make your decision, your health care providers will be available to answer any questions you have about the BPR. You can ask any information you want on the BPR.
If you decide to participate in the BPR, you will be provided with an information sheet and a consent form.
The BPR has been approved by your doctor and the Human Research Ethics Committees of hospitals around Australia.
return to topWhat information will be collected by the BPR?
Every six months during your regular assessment by your doctor, information will be collected about your health status through testing such as echocardiograms (ultrasound of heart and major blood vessels) and six minute walk tests. The Health Insurance Commission (HIC) requires this information to ensure you are eligible to continue taking bosentan. If you decide to take part in the BPR, some of this information, such as your personal details, your name, address, date of birth and Medicare number, will be released by the HIC to be stored in the BPR.
Your personal details will not be used for any other purpose than for collecting information on your health status relating to PAH.
If you stop taking bosentan for any reason, you will still be enrolled in the BPR. During the course of the three year period, you will be contacted directly by the BPR team to ask you information about your health.
return to topWho has access to this information?
The BPR is conducted in accordance with all National and State privacy laws. Any information obtained via the BPR that can identify you will remain strictly confidential. In any publication, information will be provided in such a way that you or any other participants cannot be identified.
return to topWhat if you decide to withdraw from the BPR?
The BPR is a voluntary activity associated with the prescribing of bosentan in Australia. If you decide to withdraw from the BPR, you should discuss this with your doctor. Some hospitals will require you to sign a form to confirm your decision to withdraw from the BPR. However, your access to bosentan will not be affected by your decision to withdraw.
You will also need to inform Medicare Australia of your
decision to withdraw from the BPR. You can do so by either telephoning the Medicare Australia on 1800 101 099
or by writing to the:
Client Liaison Unit
Information Services Branch
PO Box 1001
Tuggeranong ACT 2091
If you require any further assistance, contact the BPR team so they can help you with making the necessary contacts to withdraw from the BPR.
return to topWho manages the BPR?
The BPR is managed by the Centre of Clinical Research Excellence in Therapeutics at Monash University.The BPR has been made possible by financial support provided by Actelion Pharmaceuticals Australia Pty Ltd.
For more information please contact the BPR.
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