Tyne & Wear

Hundreds of patients facing medication delays

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Media captionMichelle Collingwood has had intestinal failure since August 2014

Hundreds of patients are facing delays in getting the medication they need after a medical firm was told to change its production system.

Calea makes liquid food but had to alter its processes after the Medicines & Healthcare products Regulatory Agency found they did not meet set guidance.

This has led to prescription delays for people with digestive problems.

The company said it was "working as quickly and safely as possible to meet demand".

'No defective products'

The issue arose following a routine Medicines & Healthcare products Regulatory Agency (MHRA) inspection on 24-26 June.

Problems were identified with the design of the manufacturing process that did not meet the requirements of current guidance to ensure product safety.

"Calea reduced output in order to make necessary changes. Whilst there is a backlog, progress is now being made to rectify the problem and increase supply as soon as possible," the MHRA said.

In its report the MHRA said: "Whilst no defective products have been identified to date, the changes to the production process are a precautionary, but necessary measure, needed to ensure product safety is maintained.

"Even though this contamination was found in the production area, it is important to add that we found no evidence to indicate that the products manufactured and supplied to patients during this period were contaminated."

A spokesperson for MHRA added they were "working closely with the company to safeguard the quality and safety of these important products".

Image caption Sara-Jane Hughes, an intestinal failure clinician, said it was a "perfect storm" of hot weather and interruptions to supply.

Michelle Collingwood has had intestinal failure since August 2014 and only has a small section of bowel left.

She normally receives bags of total parenteral nutrition (TPN) but a month ago she said the supply to her home in Blaydon, Gateshead, became unreliable.

Michelle does get replacement bags from her hospital but she said she needed bespoke ones and in the recent hot weather her health had suffered.

"I'm shocked it's come to this, I've been a patient with Calea for more than five years, it's the handling of the situation I can't understand," she said.

"I got a letter three weeks after it began, the communication has been absolutely appalling from them."

"It's been four weeks now and we've been told it might be another four to six weeks. I can't take any more," she added.

'Perfect storm'

It is thought about 600 people are affected, Calea said.

Sara-Jane Hughes, an intestinal failure clinician, said it was a "perfect storm" of hot weather and interruptions to supply.

A spokesperson for Calea said: "Following a routine MHRA inspection, we have been directed to change the process by which we add trace elements and vitamins to our parenteral nutrition bags, in order to align with latest standard industry practice.

"As a result the time taken to produce bags has increased and although we are working as quickly and safely as possible to meet demand, we are sorry that our deliveries have been delayed."

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