BSRBR|Newsletter - The British Society for Rheumatology
BSRBR|Newsletter - The British Society for Rheumatology
BSRBR|Newsletter - The British Society for Rheumatology
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<strong>BSRBR|Newsletter</strong><br />
Outstanding Death Data<br />
update: 50% of requests<br />
now returned<br />
We have now had over 1,200 deaths in the<br />
anti-TNF cohort reported to the BSRBR and, in the<br />
last newsletter, we outlined a particular problem we<br />
were having due to missing death in<strong>for</strong>mation in<br />
around a third of these patient deaths. One of the<br />
primary outcomes of the Biologics Register has<br />
been to study the long-term safety of anti-TNF<br />
therapy and one of the most important outcomes<br />
has been death. All patients registered with the<br />
BSRBR are flagged with the NHS In<strong>for</strong>mation<br />
Centre (<strong>for</strong>merly the Office <strong>for</strong> National Statistics).<br />
<strong>The</strong>re<strong>for</strong>e, we are notified of all deaths and receive<br />
a copy of the death certificate. Un<strong>for</strong>tunately, we<br />
do not receive in<strong>for</strong>mation on whether the patient<br />
was receiving a biologic drug at the time of death.<br />
Without these details, it may be necessary to<br />
exclude these important patients from analyses,<br />
thus losing all of their in<strong>for</strong>mation collected to date.<br />
So far we have received 212 responses from 410<br />
requests <strong>for</strong> such death in<strong>for</strong>mation so we are still<br />
have 50% outstanding. We realise how difficult it<br />
can be to obtain this in<strong>for</strong>mation when a patient<br />
has died. If you have received one of these letters<br />
and are having trouble accessing data <strong>for</strong> any<br />
reason please contact the office on<br />
biologics.register@manchester.ac.uk.<br />
➜<br />
Reminder:<br />
Continued importance of follow-up data!<br />
If important drug therapy data or details relating<br />
to a serious adverse event are missing, it will often<br />
result in data being excluded from <strong>for</strong>thcoming<br />
BSRBR analyses, limiting the usefulness of the data<br />
collected at baseline. At the same time, we do really<br />
appreciate the burden we are putting on you and your<br />
team. Again, if you would like a list of patients who are<br />
not responding to our questionnaires please contact<br />
Pat Creighton at pat.creighton@manchester.ac.uk.<br />
Reporting adverse events<br />
Abbott – Adalimumab<br />
Chiara Dell'aria Burani BSc, MSc<br />
Affiliate Safety Representative<br />
Pharmacovigilance UK, Ireland & Malta<br />
Abbott UK, Abbott House,<br />
Vanwall Business Park,<br />
Vanwall Road, Maidenhead,<br />
Berkshire SL6 4XE - UK<br />
PcV: +44 (0)800 121 8267<br />
Tel +44 (0)1628 644175<br />
Fax +44 (0)1628 644236<br />
Email:<br />
chiara.dellaria-burani@abbott.com<br />
Biovitrum – Anakinra<br />
Gema Retama<br />
Senior Pharmacovigilance Specialist<br />
Biovitrum<br />
Quintiles Drug Safety and Medical<br />
Affairs, Europe Quintiles Ireland<br />
Limited East Point<br />
Business Park Fairview<br />
Dublin 3<br />
Tel: 0035318195242<br />
Fax: 0035318099501<br />
Email: gema.retama@quintiles.com<br />
Roche – Rituximab<br />
Dr Boshishi Mohlala,<br />
Drug Surveillance Physician<br />
Drug Safety and Risk Management<br />
www.rheumatology.org.uk<br />
It is essential that in<strong>for</strong>mation on all occurrences of all adverse events on<br />
registered patients is reported promptly to the BSRBR offices at the arc EU in<br />
Manchester. All available data <strong>for</strong> each adverse event should always be provided<br />
to assist the Register’s pharmacovigilance ef<strong>for</strong>t and ensure we have the best<br />
in<strong>for</strong>mation to assess the safety of these treatments both short-term and over<br />
the life of the register.<br />
If you also notify the MHRA of a suspected adverse drug reaction or a<br />
suspected defect in a product through the yellow card scheme please will<br />
you record this in the in<strong>for</strong>mation provided to the BSBR.<br />
In addition you may also notify or seek advice from the relevant company in<br />
relation to safety <strong>for</strong> each product using the following contacts:<br />
Roche Products Limited<br />
6 Falcon Way, Shire Park<br />
Welwyn Garden City AL7 1TW - UK<br />
Tel: +44( 0)1707-367554<br />
Fax:+44 (0)1707 384504<br />
Email: boshishi.mohlala@roche.com<br />
Schering Plough – Infliximab<br />
Graham Marshall<br />
Drug Safety Manager (UK and Ireland)<br />
Schering-Plough Ltd<br />
Welwyn Garden City<br />
Hert<strong>for</strong>dshire AL7 1TW - UK<br />
Tel: +44 (0)1707 363686<br />
Fax: +44 (0)1707 363696<br />
Mob: +44 (0)777 197 3280<br />
Email: graham.marshall@sp.com<br />
Wyeth – Etanercept<br />
Catherine Binns RN<br />
Head of Drug Safety<br />
Wyeth Pharmaceuticals<br />
Huntercombe Lane South<br />
Taplow, Maidenhead<br />
Berkshire SL6 0PH - UK<br />
Tel: +44 (0)1628 604377<br />
Fax: +44 (0)1628414025<br />
Dir: +44 (0)1628 413931<br />
Mob: +44 (0)7990 530138<br />
Email: binnsc@wyeth.com<br />
For all queries about this newsletter and suggestions <strong>for</strong> future issues, please contact:<br />
Nia Taylor, BSR Biologics Register Coordinator<br />
E: ntaylor@rheumatology.org.uk<br />
W: www.rheumatology.org.uk<br />
<strong>British</strong> <strong>Society</strong> <strong>for</strong> <strong>Rheumatology</strong>, Bride House, 18-20 Bride Lane, London EC4Y 8EE<br />
Registered Charity No. 1067124 Company No. 3470316, VAT No. 404 5637 66
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