Supply disruption for all formulations of generic ranitidine – update 27 November 2019

28 Nov 2019

Supply disruption alert update 27 November 2019 – all oral and injectable preparations of ranitidine

The Department of Health and Social Care (DHSC) has issued an updated supply disruption alert (SDA) which affects the supply of both oral and injectable ranitidine preparations. This SDA follows the information previously issued by DHSC which provided information on supply disruption of all oral preparations of generic ranitidine.

The Medicines and Healthcare products Regulatory Agency (MHRA) has directed all suppliers to quarantine all affected, unreleased stock of both oral and injectable ranitidine preparations at manufacturer level whilst it continues to conduct investigations.

This means that the following ranitidine preparations will be unavailable until further notice:

Formulation type  Strengths
Effervescent tablets 150mg and 300mg
Tablets 75mg, 150mg, 300mg
Oral solution 75mg/5ml ,150mg/5ml
Injection 25mg/ml ,50mg/2ml

Pharmacists and pharmacy teams should be aware of the following advice:

  • Remaining extremely limited stock of unaffected ranitidine preparations which are still available in the supply chain and have not been recalled by the MHRA can be supplied
  • All healthcare professionals, including specialists, should not begin ranitidine treatment in any new patients
    • This includes both oral or injectable ranitidine preparations
    • Consult local specialists for advice on specific alternatives for high-risk patients (infants and children) and specialist/unlicensed indications
  • 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 has produced a table of alternative products to consider for patients requiring ongoing treatment  (page 4 of the updated SDA), key points to consider include:
    • Patients prescribed oral ranitidine preparations:
      • 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
  • Patients prescribed IV ranitidine preparations should be assessed to establish whether ongoing treatment is required – suitable alternatives should be sought as appropriate

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 November 2019.