Solving drug shortages - Mitomycin-C

A significant number of oncology patients in the UK rely on Mitomycin, a chemotherapy drug.

So when in October 2019 the Medicines and Healthcare products Regulatory Agency (MHRA) issued a supply disruption alert for Mitomycin-C, a drug licensed in over 80 countries worldwide, it was clear that in order to continue to provide patients with this vital medicine, it was essential to move quickly, act decisively, and get ahead of the problem.

Drug shortages are often unpredictable, complex, and notoriously difficult to resolve. At Clinigen we understand the burden that drug shortages have on healthcare professionals in sourcing alternatives, dealing with regulation, and providing reassurance to patients.

Raising the alarm

Mitomycin-C is almost exclusively supplied by Kyowa Kirin within the UK. Ahead of the MHRA alert, Kyowa Kirin had raised concerns over the quality of certain unexpired batches and, as a precaution, issued a recall.

Clinigen has a strong and extensive working relationship with Kyowa Kirin. This allowed our teams to discuss the potential product recall that was expected to result in increased global demand for Mitomycin-C, before the MHRA alert was released.

Taking swift action

Kyowa Kirin’s quick action meant that our team was able to move at speed. Within hours, our network of global sourcing experts had sourced an alternative supply of the medicine. In less than a week we had stock in our UK warehouse, ready to provide to clinicians.

Dotting the i’s and crossing the t’s

In meeting the demand, it was also essential that all importation documentation was processed and in place. Our partners at Accord Healthcare were able to produce the paperwork needed to meet regulatory requirements, and Clinigen engaged with the MHRA to ensure rapid approval of NOI.

Alongside this, Clinigen’s global customer services team were thoroughly trained on the upcoming shortage, ready to fast-track orders through our UK warehouse.

Department of Health

When managing shortages such as these, Clinigen communicates regularly with the Department of Health, keeping them aware of our progress in securing alternative supplies. By ensuring our warehouses were stocked with Mitomycin-C, the Department of Health were able to respond immediately to enquiries from clinicians, and inform them that Clinigen had available stock.

The Department of Health also reached out to thank us for our support in resolving the shortage.

Impact on patients

As a result of this proactive action and collaborative effort in dealing with the shortage, Clinigen was able to continue to provide Mitomycin-C to healthcare professionals, minimising the impact on supply and ensuring that patients continued to receive the treatment they needed.

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