Dextropropoxyphene: Pain-killers containing dextropropoxyphene - Di-Gesic and Doloxene, 10 October 2013

Implementation of conditions

New conditions on the registration and supply of dextropropoxyphene-containing pain-killers Di-Gesic and Doloxene will take effect from 10 October 2013.

However, requirements involving the use of the new Prescriber Confirmation form imposed by the Administrative Appeals Tribunal (AAT) will not come into operation immediately. The sponsor is required to write to doctors, dentists and pharmacies advising them about the conditions and what will be required of them in relation to the new Prescriber Confirmation form.

On 12 September 2013, the AAT imposed certain conditions on the registration of Di-Gesic and Doloxene to ensure the safe use of these products. This allows them to remain on the Australian Register of Therapeutic Goods (ARTG), and therefore continue to be marketed in Australia.

The TGA will not be appealing the decision of the AAT in the Federal Court. Any such appeal would have been limited to questions of law, rather than the scientific or medical merits of the decision, and would have delayed the implementation of the conditions imposed by the AAT designed to ensure the safe use of Di-Gesic and Doloxene. The TGA believes safeguards that the AAT found were necessary to ensure the safe use of these products through the imposition of these conditions should be in place as soon as possible.

The TGA will be publishing a set of Q&As about the conditions shortly. Meanwhile, background information about the AAT's decision can be found in an update published on the TGA website on 19 September 2013.

Implementation process

The conditions take effect on and from 10 October 2013 (28 days after the AAT's decision).

The sponsor will have until 24 October 2013 (14 days) to lodge an application with the TGA to vary the Product Information (PI) documents for Di-Gesic and Doloxene.

Within 30 days of the PI changes being approved by the TGA, the sponsor is required to write to doctors, dentists and pharmacies to provide further information about the conditions and advise when to start using the new Prescriber Confirmation form.

Conditions

The conditions imposed by the AAT will require the sponsor to have arrangements in place designed to ensure that doctors and dentists sign a new Prescriber Confirmation form when prescribing Di-Gesic or Doloxene, confirming that they:

• are aware that the medicine is only approved for use in patients not able to be adequately treated with other mild pain-killers
• have considered the contraindications for the medicine outlined in the PI and have explained them to the patient at the time of prescribing
• have considered any recent changes to the patient's clinical presentation or biochemical status
• have warned the patient at the time of prescribing about appropriate use of the medicine
• are satisfied at the time of prescribing that that the patient's history does not indicate that the patient is at risk of accidental or intentional self-harm.

The conditions will also require the sponsor to have arrangements in place designed to ensure that the signed Prescriber Confirmation form is presented to the pharmacist dispensing these medicines before supplying them to the patient.

The conditions provide for the auditing of pharmacies to ensure that the new forms are collected as required.

Information for consumers

If you are being treated with these medicines, there will be no immediate changes to the way you are prescribed or supplied this medicine.

Once the requirement to use the new Prescriber Confirmation form comes into operation, your doctor or dentist will need to complete the new form when prescribing Di-Gesic or Doloxene to ensure the safe use of those medicines.

Under the conditions, the dispensing pharmacist will need to have a completed Prescriber Confirmation form before the medicines can be supplied to you. The pharmacist will also offer you a Patient Information Sheet.

Information for health professionals (doctors, dentists and pharmacists)

While the new conditions come into effect on 10 October 2013, requirements for prescribers to use the new Prescriber Confirmation form will not come into operation immediately. The sponsor is required to write to doctors, dentists and pharmacies advising when to start using the new form when prescribing Di-Gesic or Doloxene.

Doctors and dentists will be contacted by the sponsor within 30 days of the PI changes being approved by the TGA to provide further information about the conditions and copies of the Prescriber Confirmation form. Also within 30 days of the PI changes being approved by the TGA, pharmacists will be contacted by the sponsor to provide further information and copies of the Patient Information Sheets. The use of the Prescriber Confirmation Form by the doctor or dentist and the requirement for the dispensing pharmacist to have a copy of the form before dispensing the medicines will occur within 60 days of the PI changes being approved by the TGA.

Requirements to use the new Prescriber Confirmation form will not come into operation until the sponsor has contacted doctors, dentists and pharmacies as described above.

The sponsor will continue to undertake a range of activities to support the compliance with the new conditions.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.