Lamotrigine contingency plan activation

28 November 2019

[name and contact details redacted]

Dear [name redacted]

REQUEST FOR INFORMATION

Thank you for your request dated 31 October 2019 under the Official Information Act 1982 for information relating to the brand change for lamotrigine.

You asked when PHARMAC activated its lamotrigine contingency plans and why. The lamotrigine contingency plan outlines an ongoing programme of work monitoring the lamotrigine brand change. There was no specific date of activation. PHARMAC is having regular meetings with Medsafe, and has done so since implementation began, about any potential or actual lamotrigine adverse event reports and Medsafe’s analysis of them.

You asked how many sentinel events PHARMAC considers have occurred relating to this brand switch and what the details of these events are. PHARMAC has not directly received any reports of sentinel events attributed to the brand change, although we have been advised by Medsafe of four deaths where the people who died were taking lamotrigine. We don’t have any of the details surrounding their cases.

You asked PHARMAC to provide you with the reports, emails and communications between PHARMAC and Medsafe in relation to the activation of these contingency plans and reports of a sentinel event. PHARMAC is in regular communication with Medsafe, including as part of this brand change. Documents relevant to this question, up until 31 October, are in the attached file. [PDF, 7.8 MB]

You asked PHARMAC to provide you with the reports, emails and communications between PHARMAC and the Minister of Health in relation to the activation of these contingency plans and reports of a sentinel event. Documents relevant to this question, up until 31 October, are also in the attached file [PDF, 7.8 MB].

You asked PHARMAC to provide you with the reports, emails and communications between PHARMAC and CARM in relation to the activation of these contingency plans and reports of a sentinel event. There have been no reports, emails or communications that relate to your request.

You asked PHARMAC to provide you with the emails and reports from the Medical Director of PHARMAC to all clinical groups and nominated contacts in relation to these contingency plans and reports of a sentinel event. There have been no reports, emails or communications that relate to your request.

Please note that PHARMAC approaches its assessment of requests for information under the OIA on the basis that, once released, the information becomes publicly available - in other words once we release the information to you it becomes available to any other party in that exact form (whether by you distributing it to others or by virtue of us receiving the same request from a different third party).  We have redacted a small amount of information from the documents as we consider this is necessary to protect the privacy of natural persons (section 9(2)(a)).

As required under the OIA, we also considered whether, in the circumstances, the withholding of this information was outweighed by other considerations which render it desirable, in the public interest, to make this information available.  In this case we did not consider that the public interest outweighed the reasons for withholding the information.  Please note you have the right, by way of complaint under section 28(3) of the OIA to an Ombudsman, to seek an investigation and review of our decision.

We trust that this information answers your queries.  We are making our information more freely available, so we will now publish selected OIA responses (excluding personal details) on our website.  Please get in touch with us if you have any questions about this.

Yours sincerely

Alison Hill
Director, Engagement and Implementation