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PSNC monitoring generics shortages as Bristol Labs suspension extended

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MHRA has stressed there is no evidence of defective medicines
MHRA has stressed there is no evidence of defective medicines

PSNC has told C+D it will continue to monitor generics shortages “very closely” after Bristol Laboratories had its manufacturing suspension extended.

The Medicines and Healthcare products Regulatory Agency (MHRA) first issued a partial suspension of the manufacturer’s licence in August 2017, after it “identified non-compliance with good manufacturing practice” during an inspection of its Luton site in July, the watchdog told C+D last week (April 12).

Two further inspections, carried out in November 2017 and January 2018, “determined that non-compliance issues remain, and so we have extended the partial suspension”, the MHRA added.

Initial shortages had “severe” impact

Pharmaceutical Services Negotiating Committee (PSNC) chief executive Sue Sharpe told C+D: “The shortages experienced by contractors following the problems at Bristol Laboratories had a severe impact and contributed to the extreme pressures of recent months.”

While Bristol Laboratories’ extended suspension “should not create new problems”, Ms Sharpe stressed, the negotiator “will continue to monitor generic supply and shortages very closely and apply for price concessions as appropriate”.

Shortages will be monitored alongside PSNC’s “ongoing work [to] ensure contractors are protected from adverse events or activity further up the supply chain”, Ms Sharpe added.

Why has the suspension been extended?

The MHRA identified two non-compliance issues with the manufacturer, relating to the “recording of key data”, and its “ongoing stability monitoring programme”, which monitors a product over its shelf life.

Bristol Laboratories told C+D it disputed information relating to the extended suspension, but did not respond to C+D’s numerous requests for further comment.

Partial suspension

Bristol Laboratories’ manufacturing facility in Luton has the capacity to produce nine billion tablets a year, according to its website, and provides medicines used to treat conditions such as diabetes, depression and Parkinson’s.

Following the initial inspection of the facility in July 2017, the MHRA said in a statement that Bristol Laboratories had been suspended from providing “batches of non-critical product” to “EU markets while this statement of non-compliance remains in force”.

The suspension has been extended to November 22, according to the MHRA’s list of suspended licences, and will be lifted when “all the non-compliances have been addressed”, the watchdog added.

“No evidence of defective medicines”

The MHRA stressed there is “no evidence of medicines being defective and therefore patients should continue to take their medicines as necessary”.

“For those products that Bristol [Laboratories] is no longer able to supply, we are working closely with the Department of Health and Social Care and other generics suppliers to ensure supplies continue to remain available for UK patients.”

3 Comments
Question: 
Are you currently experiencing shortages of any generics?

Mr CAUSTIC, Community pharmacist

I hate to think what the suspension has cost the nhs and contractors . We should be told the exact problems found with both companies   that were closed down at the same time .If there are no problems with the product was it necessary to cause all this chaos. If there was a problem the public also has a right to know what it was. Strange the UK authorities did not stop production but only supply inside the EEC. Perhaps the rest of the world might question why they are still allowed these products from the UK that are not good enough for the EEC patients. What would happened if we had left the EEC ? Ban release in the UK and let the rest of the world have them  ?

 

 

 

A B, Community pharmacist

From what I gather, the suspension relates to paperwork issues such as record keeping and not the actual manufacturing process.

I attended an LPC meeting where a speaker from the PSNC said that the NHS still needed bristol to carry on producing vital medication. So because the issue was not the actual quality of the product the MHRA would still allow them to distribute certain items to certain places.

A strange situation indeed, I don't claim to understand it and I haven't heard a full explanation from anyone in the know.

Adam Hall, Community pharmacist

Am I being suspicious when I think that this extension of suspension by MHRA should have been followed by a raft of concessionary pricing from DoH - or is this collusion between Government departments to further erode the pharmacy sector? Who can tell?

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