Escitalopram supply issues
Thank you for your request dated 15 May 2024 under the Official Information Act 1982 (the Act) for information relating to escitalopram.
Some of the information you have requested is held by the Ministry of Health (the Ministry), However, your request was directed to both Pharmac and the Ministry. Therefore, it is not necessary for Pharmac to transfer these parts of your request under section 14(b)(ii) of the Act. The parts of your request that will be responded to by the Ministry will be demarcated below:
At 3rd November 2023, did IPCA-Escitalopram have full and complete Medsafe approval? Has the status of that approval changed since 3rd November 2023?
Please refer to the response you will receive from the Ministry in due course (H2024041544 refers).
On your website, you refer to a temporary inability to supply Medsafe-approved tablets of the 10mg variety for IPCA-Escitalopram. What was the cause of this supply issue?
Please refer to the summary of communications provided below under section 16(1)(e) of the Act.
As at 15th May 2024, has Pharmac or Medsafe begun implementing the Coalition Government’s “rule of two” which allows overseas regulators to dictate approval?
Please refer to the response you will receive from the Ministry in due course (H2024041544 refers).
Please provide the following information: Any communications between Pharmac and Miro concerning escitalopram from April 2023 to May 2024.
I have identified 16 email chains within the scope of your request. These documents have been withheld under section 9(2)(ba)(i) of the Act, to protect the supply of similar information in the future. Pharmac relies on suppliers being candid and upfront when supply issues arise, and there may be a chilling effect on communications from suppliers in the future if their communications concerning supply issues were released under the Act. I have decided that the need to preserve this channel of communication outweighs the public interest in release of these communications.
However, I can provide you with a summary of the communications under section 16(1)(e) of the Act.
In November 2023, Miro Pharmaceuticals (the supplier) advised Pharmac that the manufacturer (IPCA Laboratories) of IPCA-Escitalopram would need to submit a ‘change medicine notification’ to Medsafe to register a new source of Active Primary Ingredient (API).
You can find more information about ‘change medicine notifications(external link)’ on the Medsafe website.(external link)
In short, a sponsor of a product (in this case, the manufacturer) is required to notify Medsafe of a planned change to an approved product.
The change in question was a change in the manufacturing process for the API. This change was being made by the existing producer of the API (Neuland). The manufacturer therefore needed to obtain an alternative source of the API, from a different producer. This change required assessment by Medsafe of the suitability of the new API supplier site including validation of production batches using the new API and evidence the site had a current GMP.
Production of the validation batches using the new API was undertaken in January 2024 and the stock shipped to New Zealand under quarantine. At the time Miro still had stock of the approved product and was releasing it to market, however, there was no further approved API available to manufacture more stock.
Miro advised Pharmac that the first validation batch test results had been completed and submitted to Medsafe at the end of January 2024. The second and third batch results were submitted to Medsafe in early March 2024. By late March the supplier had two months of stock in country under quality hold.
On 3 May 2024, Medsafe approved the change medicine notification and the stock that was under quality hold was able to be distributed, resolving the supply issue.
Pharmac remained in contact with Miro throughout this process and received regular updates on the existing stock. Pharmac also worked closely with Medsafe to assist where possible with the approval process.
Unfortunately, this process necessitated some people swapping their brand of escitalopram multiple times within a short space of time while the supply issues were resolved. I understand how frustrating and unnerving this was for some people, especially considering that this is a medication that is used primarily for the treatment of anxiety, depression or other mental health issues. Please be assured that Pharmac works hard to ensure as little disruption for patients as possible when supply issues arise.
Any information (meeting minutes, emails, etc) concerning the Medsafe approval of IPCA-Escitalopram.
Please refer to the response you will receive from the Ministry in due course (H2024041544 refers).
Any complaints received by Pharmac or Medsafe concerning IPCA-Escitalopram.
Pharmac has not received any formal complaints concerning IPCA-Escitalopram