Dextropropoxyphene: questions and answers

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7 January 2014
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Consumer questions

Due to safety concerns associated with use of medicines containing dextropropoxyphene, including heart rhythm disorder, the TGA made a decision to cancel a number of these products from the Australian Register of Therapeutic Goods (ARTG), including Di-Gesic and Doloxene. The sponsor of Di-Gesic and Doloxene, Aspen Pharmacare Australia, challenged these decisions in the Administrative Appeals Tribunal (AAT).

On 12 September 2013, the AAT made a decision that Di-Gesic and Doloxene should remain on the ARTG, but imposed conditions that the AAT found were necessary to ensure the safe use of these medicines.

The conditions require Aspen Pharmacare Australia to have arrangements in place designed to ensure that doctors and dentists complete and sign a new Prescriber Confirmation Form when prescribing Di-Gesic or Doloxene and pharmacists only dispense these medicines if the patient has provided a signed Prescriber Confirmation Form.

The requirement to obtain a completed and signed Prescriber Confirmation Form from your doctor/dentist and provide it to your pharmacist so that you can be dispensed Di-Gesic or Doloxene will commence on 1 January 2014.

If you have any concerns you should discuss them with your doctor.

There are a number of safety concerns associated with inappropriate use of medicines containing dextropropoxyphene, including Di-Gesic and Doloxene. A summary of the safety concerns are described in the document 'Important Patient Information regarding Di-Gesic and Doloxene' which can be obtained from your pharmacist. It is very important that you read this information.

Alternative therapies may be available for you. If you have any questions or concerns about the use of Di-Gesic or Doloxene, or you want to find out more about alternative therapies, speak to your doctor.

You should tell your doctor about any other medicines, including vitamins and herbal remedies, you are taking before you are prescribed Di-Gesic or Doloxene.

If you have any questions or concerns about the use of this medicine, including potential interaction with other medicines, speak to your doctor.

If you suspect that you are experiencing an adverse event while taking Di-Gesic or Doloxene you should seek medical attention. Also, as with all other medicines, if you experience an adverse event while taking these products, you should notify the TGA (by visiting www.tga.gov.au and clicking on 'Report a problem') and the sponsor, Aspen Pharmacare Australia (by calling 1300 659 646). This information will contribute to the TGA's ongoing monitoring of the safety of these products.
A signed Prescriber Confirmation Form needs to be provided to the dispensing pharmacist when obtaining the initial supply of a prescription for Di-Gesic or Dolexene, but not for repeats from that same prescription. Each time you return to your doctor for another prescription, your doctor will need to complete and sign another Prescriber Confirmation Form.
You need to go back to your doctor and ask for a signed Prescriber Confirmation Form.
You are not restricted to buying Di-Gesic or Doloxene from the same pharmacy every time. A signed Prescriber Confirmation Form is needed for the initial supply of a prescription for Di-Gesic or Doloxene, but not for repeats from that same prescription.
Contact your doctor and ask for a Prescriber Confirmation Form. Each time you return to your doctor to renew your prescription, your doctor will need to complete and sign another Prescriber Confirmation Form.
A signed Prescriber Confirmation Form needs to be provided to the dispensing pharmacist when obtaining the initial supply of a prescription for Di-Gesic or Dolexene, but not for repeats from that same prescription. If you lose or misplace the Prescriber Confirmation Form before the initial supply, you will need to obtain another completed and signed Prescriber Confirmation Form from your doctor.

The conditions imposed on the sponsor, Aspen Pharmacare Australia, by the Administrative Appeals Tribunal involve a completed and signed Prescriber Confirmation Form being provided by a prescriber to a patient, who will then present the form to their pharmacist along with the prescription for Di-Gesic or Doloxene.

The prescriber will keep a copy of the Prescriber Confirmation Form, the patient will keep a copy and the pharmacist will keep two copies, the 'pharmacy copy' and the 'audit copy', in case the pharmacy is selected for audit.

If a pharmacy is selected for audit, Aspen Pharmacare Australia, or an independent third party, will collect the 'audit copy'. The 'audit copy' will not contain identifying information concerning patients or prescribers.

Further enquiries regarding the Prescriber Confirmation Form and concerns regarding confidentiality of personal information should be directed to Aspen Pharmacare Australia by calling 1300 659 646.

A number of countries have withdrawn approval for dextropropoxyphene-containing products, including the United States, Canada, New Zealand, the United Kingdom, the European Union, Singapore, South Africa and India.

This is due to emerging evidence and recognition of the potential safety risks associated with dextropropoxyphene-containing products, including heart rhythm disorder, which may cause sudden death. Even a small overdose of dextropropoxyphene may be fatal.

Due to these safety concerns, the TGA made a decision to cancel a number of products containing dextropropoxyphene from the Australian Register of Therapeutic Goods (ARTG), including Di-Gesic and Doloxene. The sponsor of Di-Gesic and Doloxene, Aspen Pharmacare Australia, successfully challenged these decisions in the Administrative Appeals Tribunal (AAT).

On 12 September 2013, the AAT made a decision that Di-Gesic and Doloxene should remain on the ARTG, but imposed conditions that the AAT found were necessary to ensure the safe use of these medicines.

Doctor/Dentist questions

The Prescriber Confirmation Form can be obtained from Aspen Pharmacare Australia by calling 1300 659 646.
Requirements involving the use of the Prescriber Confirmation Form have been imposed on the sponsor, Aspen Pharmacare Australia, by the Administrative Appeals Tribunal. There are no conditions placed directly on prescribers. However, if you do not use the form, your patient will not be able to obtain Di-Gesic or Doloxene from a community pharmacy.
The conditions imposed by the Administrative Appeals Tribunal require the sponsor, Aspen Pharmacare Australia, to have arrangements in place designed to ensure that doctors and dentists complete and sign a new Prescriber Confirmation Form when prescribing Di-Gesic or Doloxene. As part of these arrangements, pharmacies should only dispense the initial supply of a prescription for Di-Gesic or Doloxene if the patient has provided a completed and signed Prescriber Confirmation Form. If you prescribe Di-Gesic or Doloxene for a patient without completing and signing a Prescriber Confirmation Form, the pharmacy should not dispense it to the patient.
The requirement to provide a completed and signed Prescriber Confirmation Form to your patients in order for them to be dispensed Di-Gesic or Doloxene will commence on 1 January 2014.

The conditions imposed by the Administrative Appeals Tribunal (AAT) on the sponsor, Aspen Pharmacare Australia, apply to all patients who are prescribed Di-Gesic or Doloxene, including those who have previously used these products, other than those who receive these medicines while admitted to hospital.

However, the requirements involving the use of the new Prescriber Confirmation Form do not come into operation immediately. The conditions imposed by the AAT require the sponsor to write to doctors, dentists and pharmacies (by 7 December 2013) advising when they need to start using the new Prescriber Confirmation Form. The requirement to provide a completed and signed Prescriber Confirmation Form in order to be dispensed Di-Gesic or Doloxene will commence on 1 January 2014.

The conditions imposed by the Administrative Appeals Tribunal (AAT) on the sponsor, Aspen Pharmacare Australia, apply to all patients who are prescribed Di-Gesic or Doloxene, other than those who receive these medicines while admitted to hospital.

However, the requirements involving the use of the new Prescriber Confirmation Form do not come into operation immediately. The conditions imposed by the AAT require the sponsor to write to doctors, dentists and pharmacies (by 7 December 2013) advising when they need to start using the new Prescriber Confirmation Form. The requirement to provide a completed and signed Prescriber Confirmation Form in order to be dispensed Di-Gesic or Doloxene will commence on 1 January 2014.

You may consider using the Prescriber Confirmation Form from 7 December 2013 to ensure continuity of supply once the requirement for pharmacies to collect completed and signed forms commences, which will be on 1 January 2014.

A completed and signed Prescriber Confirmation Form is needed for the initial supply of a prescription for Di-Gesic or Doloxene, but not for repeats from that same prescription.

The conditions imposed by the Administrative Appeals Tribunal on the sponsor, Aspen Pharmacare Australia, apply to all patients who are prescribed Di-Gesic or Doloxene, including those who have previously used these medicines, other than those who receive these medicines while admitted to hospital.

Once the requirement to use the Prescriber Confirmation Form comes into operation, each time a patient comes to you for a new prescription, you will need to complete and sign a new form.

The decision as to whether a patient is suitable to be treated with other mild analgesics lies within the medical expertise of the treating doctor.
As with all other medicines, if your patient suffers an adverse event while taking Di-Gesic or Doloxene, you should notify the TGA (by visiting www.tga.gov.au and clicking on 'Report a problem') and the sponsor, Aspen Pharmacare Australia (by calling 1300 659 646). This information will contribute to the TGA's ongoing monitoring of the safety of these products.

The conditions imposed on the sponsor, Aspen Pharmacare Australia, by the Administrative Appeals Tribunal involve a completed and signed Prescriber Confirmation Form being provided by prescribers to the patient, who will then present the form to their pharmacist along with the prescription for Di-Gesic or Doloxene.

The prescriber will keep a copy of the Prescriber Confirmation Form, the patient will keep a copy and pharmacist will keep two copies, the 'pharmacy copy' and the 'audit copy', in case the pharmacy is selected for audit.

If a pharmacy is selected for audit, Aspen Pharmacare Australia, or an independent third party, will collect the 'audit copy'. The 'audit copy' will not contain identifying information concerning patients or prescribers.

Further enquiries regarding the Prescriber Confirmation Form and concerns regarding confidentiality of personal information should be directed to Aspen Pharmacare Australia by calling 1300 659 646.

The 'pharmacy copy' of the Prescriber Confirmation Form is not de-identified. However, the 'audit copy' provided by a pharmacy to the sponsor, Aspen Pharmacare Australia, or an independent third party, to comply with auditing requirements will be de-identified. That is, it will not contain the name of the patient or the name of the prescriber.

The conditions imposed on Aspen Pharmacare Australia by the Administrative Appeals Tribunal require that the sponsor write to doctors, dentists and pharmacies (by 7 December 2013) advising them about the conditions and what will be required of them in relation to the Prescriber Confirmation Form.

Further enquiries regarding the Prescriber Confirmation Form should be directed to Aspen Pharmacare Australia by calling 1300 659 646.

You should inform the sponsor, Aspen Pharmacare Australia by calling 1300 659 646. The conditions imposed by Administrative Appeals Tribunal were considered necessary to ensure the safe use of Di-Gesic and Doloxene, and non-compliance with the requirements involving the use of the new Prescriber Confirmation Form exposes patients to the risks associated with inappropriate prescribing/use of these medicines.

Hospital Doctor/Pharmacy question

Hospital pharmacies are not required to obtain a signed Prescriber Confirmation Form when dispensing Di-Gesic or Doloxene to a patient who is admitted to hospital, however must obtain a signed Prescriber Confirmation Form if dispensing to a patient who is not admitted to hospital.

For this reason, it is not necessary for prescribers to complete and sign a Prescriber Confirmation Form when prescribing Di-Gesic or Doloxene for a patient who is admitted to hospital where the product will be dispensed by a hospital pharmacy while the patient remains admitted. However, where a patient who is admitted to hospital is provided with a prescription for Di-Gesic or Doloxene to be used at a later time when they are not admitted to hospital (for example, where the prescription is to be dispensed in a community pharmacy) it will be necessary for prescribers to complete and sign a Prescriber Confirmation Form for that patient.

Pharmacist questions

This new scheme is expected to continue for as long as Di-Gesic and Doloxene remain on the Australian Register of Therapeutic Goods (ARTG).

Due to safety concerns arising from emerging evidence regarding potential safety risks associated with dextropropoxyphene-containing products, the TGA made a decision to cancel a number of those products from the ARTG, including Di-Gesic and Doloxene. The sponsor of Di-Gesic and Doloxene, Aspen Pharmacare Australia, successfully challenged these decisions in the Administrative Appeals Tribunal (AAT).

On 12 September 2013, the AAT made a decision that Di-Gesic and Doloxene should remain on the ARTG and imposed conditions that the AAT found were necessary to ensure the safe use of these products.

A completed and signed Prescriber Confirmation Form needs to be provided to the dispensing pharmacist for the initial supply, but not for repeats from that same prescription, even if they are dispensed at a different pharmacy.
The requirement to sight and collect a completed and signed Prescriber Confirmation Form before you dispense an initial supply of a prescription for Di-Gesic or Doloxene will commence on 1 January 2014.

In accordance with the proposed Enforceable Agreement between yourself and the sponsor, Aspen Pharmacare Australia, you should not dispense the initial supply of a prescription for Di-Gesic or Doloxene until you obtain a completed and signed Prescriber Confirmation Form for that patient.

The conditions imposed by the Administrative Appeals Tribunal requires the sponsor to write to doctors, dentists and pharmacies (by 7 December 2013) advising them about the conditions and what will be required of them in relation to the new Prescriber Confirmation Form. Further enquiries regarding the Enforceable Agreement should be directed to Aspen Pharmacare Australia by calling 1300 659 646.

In accordance with the proposed Enforceable Agreement between yourself and the sponsor, Aspen Pharmacare Australia, you should not dispense the initial supply of a prescription for Di-Gesic or Doloxene until you obtain a completed and signed Prescriber Confirmation Form for that patient.

However, the requirement for pharmacies to collect completed and signed Prescriber Confirmation Forms does not come into operation immediately. The conditions imposed by the AAT require the sponsor to write to doctors, dentists and pharmacies advising when they need to start using the new Prescriber Confirmation Form by 7 December 2013. The requirement to provide a completed and signed Prescriber Confirmation Form in order to be dispensed Di-Gesic or Doloxene will commence on 1 January 2014.

If a patient presents an original prescription of Di-Gesic or Doloxene that is dated prior to 1 January 2014 and does not have a completed and signed Prescriber Confirmation Form, and it is unclear what you should do to comply with the Enforceable Agreement, contact Aspen Pharmacare Australia by calling 1300 659 646.

Pharmacies need to keep copies (the 'pharmacy copy' and 'audit copy') of the Prescriber Confirmation Forms, as the sponsor, Aspen Pharmacare Australia, is required to conduct audits on this process. This must be done in accordance with the proposed Enforceable Agreement between yourself and the sponsor, i.e. two years.

Further enquiries regarding the Enforceable Agreement should be directed to Aspen Pharmacare Australia by calling 1300 659 646.

All enquiries regarding the audits the sponsor will be conducting to comply with the conditions imposed by the Administrative Appeals Tribunal should be directed to Aspen Pharmacare Australia by calling 1300 659 646.
As with all other medicines, if your patient suffers an adverse event while taking Di-Gesic or Doloxene, you should notify the TGA (by visiting www.tga.gov.au and clicking on 'Report a problem') and the sponsor, Aspen Pharmacare Australia by calling 1300 659 646. This information will contribute to the TGA's ongoing monitoring of the safety of these products.
If you do not receive, upon request, a hard copy of the CMI or patient information sheet from Aspen Pharmacare Australia, inform the TGA by emailing info@tga.gov.au.