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Welcome to the TYSABRI ® Australian Prescribing Program (TAPP) training.
TYSABRI® (natalizumab) was approved by the Therapeutic Goods Administration
(TGA) on 30 October 2006. The conditions for granting marketing approval include
the compulsory registration and education of neurologists, pharmacies and
infusion centres.
This program is an educational platform for neurologists and other healthcare
professionals. TAPP is designed to:
- Ensure that those patients most likely to benefit from treatment receive
TYSABRI
- Assist neurologists to appropriately assess the benefit/risk balance for each
of their patients.
- Ensure that TYSABRI is discontinued earlier rather than later if symptoms
and/or signs appear
consistent with PML
TAPP consists of:
- Neurologists - compulsory prescribing program
- Pharmacy and infusion centre staff - compulsory training focusing on
dispensing, administration and patient monitoring
- All trained healthcare professionals to be recorded in a dedicated database
(TAPP database) as per TGA reporting requirements.
The TAPP database has been custom-made for the TYSABRI® Australian
Prescribing Program.
The main objective of the database is to facilitate reporting
to TGA and to manage the commitments Biogen Idec has made to the TGA, which
are:
- Rollout and tracking of training requirements for healthcare professionals
Managing 6-monthly follow-ups to neurologists on patient exposure and
adverse events
- Biogen Idec must actively solicit and submit to the TGA 6-monthly updates
from neurologists registered with the sponsor as potential prescribers of
TYSABRI®
- These updates must include:
- Number of patients treated
- Dose received by each patient
- Duration of treatment
- Current status of each patient
- Presence and nature of adverse drug reactions.
TAPP will focus on clinical monitoring by Healthcare Professionals as the most
appropriate risk management approach for treatment of relapsing remitting
multiple sclerosis patients with TYSABRI®.
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