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Ranitidine still out of stock, after 1 year of disrupted supply

Ranitidine continues to be out of stock, one year after the Department of Health and Social Care (DH) said some products would be unavailable “until further notice”.

At the end of April 2020, the European Medicines Agency’s (EMA) human medicines committee recommended the suspension of all ranitidine formulas due to the presence of low levels of N-nitrosodimethylamine (NDMA), a risk factor for some cancers.

With ranitidine film-coated tablets, effervescent tablets and oral solution already unavailable at the time, last May the DH issued a supply notification indicating that ranitidine 50mg/2ml injection was “anticipated to be unavailable from the end of May 2020 until further notice”.

Following discussions with the DH and manufacturers, C+D understands that supplies of all preparations of the antacid drug continue to face disruption, and a recently updated Medicine Supply Notification on March 30 called on clinicians to continue to use alternative medications.

"Ongoing disruption"

A DH spokesperson told C+D last week (April 16): “We are aware of an ongoing disruption affecting the supply of all ranitidine products from all suppliers due to global regulatory investigations.

“The government has issued comprehensive guidance to health care professionals to support the management of patients who may be impacted by this supply issue.

“Any patient affected should discuss alternative treatment options with their pharmacist or doctor.”

Manufacturer has “no plans” for reintroduction

C+D contacted major manufacturers of ranitidine products Sanofi, Zentiva and Teva.

Teva told C+D: “At the moment we have no plans to reintroduce ranitidine back into the UK market.”

The suspension of manufacturing and distribution globally had been a “precautionary measure”, it said, adding: “We are constantly reviewing our portfolio to ensure we can best serve our patients and customers, and we remain committed to providing high-quality medicines that are both safe and effective.”

A Zentiva spokesperson responded: “We currently do not stock this line.”

Sanofi did not respond to C+D's request for comment before the time of publication.

“Frustration” for patients; “massive” amount of work for pharmacists

According to Laura Buckley, a lead primary care network pharmacist for the NHS, when ranitidine products were initially discontinued, pharmacists were faced with a “massive” amount of work to find suitable alternatives for patients – particularly, she told C+D, because “there wasn’t a blanket alternative for everybody” due to different medical histories.

“There was a lot of frustration there from patients, because those that had been stabilised on this particular drug [where] it was working really well for them were suddenly looking at change and were looking at other medicines,” Ms Buckley said.

Currently, patients who were on ranitidine “are almost half-heartedly hoping that it will come back in stock, because lots of people found it to be really effective for them”, she explained. However, “some people found that actually making those changes did make a really positive difference”.

Read C+D's clinical article: How will your patients be affected by the ranitidine recall?

How have you dealt with the ranitidine supply issues?

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