Supply disruption for all oral preparations of generic ranitidine

Supply disruption alert – all oral preparations of generic ranitidine are expected to be out of stock with no date of anticipated availability

A Supply Disruption Alert has been issued by the Department of Health and Social Care (DHSC) stating that all oral preparations of generic ranitidine are expected to be out of stock with no date of anticipated availability.

The contaminant, N-nitrosodimethylamine (NDMA), has been identified in samples of ranitidine active substance; all UK-manufactured stock has been quarantined whilst the Medicines and Healthcare products Regulatory Agency (MHRA) conducts investigations.

A Class 2 medicines recall drug alert (Ref: EL(19)A/24) was also recently issued by the MHRA for all unexpired stock of four Zantac products.

The following oral formulations of ranitidine are affected:

* Over-the-counter generic ranitidine tablets are also affected by the supply disruption

Pharmacists and pharmacy teams should be aware of the following:

• Remaining limited stock of unaffected oral ranitidine preparations which are still in the supply chain should be reserved for patients in whom specialists have considered that there are no clinically suitable alternative treatment options
• Some IV ranitidine stock has been affected; however, there is adequate stock of unaffected IV ranitidine to meet current UK demand
  • IV ranitidine stock is under review and this situation may change
• Patients requesting repeat prescriptions of any oral ranitidine preparation should be reviewed to assess whether ongoing treatment is needed; prescribers should supply clinically appropriate alternatives
  • DHSC recommends that prescribers and pharmacists work together closely to achieve a better understanding of treatment options
  • Patients should be referred to a specialist where there is no clinically appropriate alternative
• DHSC has produced a table of alternative products to consider for patients requiring ongoing treatment  (page 3 of the Supply Disruption Alert); key points to consider include:
  • Omeprazole is the first-line choice of proton pump inhibitor, where clinically appropriate
    • There is currently sufficient stock of omeprazole to meet an increase in demand

• Patients should not be switched to a different H2-receptor antagonist (such as cimetidine) – this may reduce the availability of these products which are sufficient to meet current demand

Pharmacists requested by prescribers to provide advice on clinically suitable alternatives should request a full medication history for the patient from the prescriber, where appropriate, before suggesting alternatives.

For further information on this or any other query, please contact the NPA Pharmacy Services team on 01727 891 800 or email pharmacyservices@npa.co.uk.

 Produced by the NPA Pharmacy Services team October 2019.