Supply Notice – Ranitidine all formulations updated 27th November 2019

Supply Notice – Ranitidine all formulations updated 27th November 2019

November 27, 2019

Further to the previous ranitidine supply disruption alert (SDA/2019/005) issued on 15 October 2019, this is an update on the supply status of both ranitidine oral and injectable products.

As investigations into ranitidine have progressed, the Medicines and Healthcare products Regulatory Agency (MHRA) have instructed suppliers of both oral and injectable ranitidine in the UK to quarantine all affected, unreleased stock at manufacturer level whilst their investigations are ongoing.

Ranitidine tablets, effervescent tablets and oral solution are expected to be out of stock with no date for resupply until further notice.

Ranitidine injection is now also expected to be out of stock imminently with no date for resupply until further notice.

All oral formulations of Ranitidine are anticipated to be out of stock, with no date for resupply until further notice.

Extremely limited supplies remaining in wholesalers and pharmacies, which have not been recalled by the MHRA, are available and can be supplied.

No new patients should be initiated on treatment with ranitidine oral or injectable products.

All patients should be reviewed as repeat prescriptions are requested and if ongoing treatment is required, be switched to clinical alternatives.

The full alert can be viewed here

Action

All healthcare professionals in primary, secondary or specialist healthcare services who prescribe or dispense ranitidine, should for:

Oral ranitidine

Licensed use for gastrointestinal conditions

  • Do not initiate treatment with oral ranitidine in new patients.
  • Identify current patients prescribed ranitidine tablets, effervescent tablets and oral solution, and review to establish if ongoing treatment is still required.
  • If ongoing treatment is still required, then consider switching to an alternative oral treatment (see table 1). It is recommended that, where possible, patients are not switched to an alternative H2 receptor antagonist in the first instance as this may exacerbate a shortage of these products. There are currently sufficient supplies of oral omeprazole to manage an increase in demand.

Specialist indications

  • Do not initiate treatment with oral ranitidine in new patients.
  • Local specialists should be consulted for advice on alternatives for specialist / unlicensed indications
    and high-risk cohorts of patients, including paediatrics.

Ranitidine injection

  • Do not initiate treatment with ranitidine injection in new patients.
  • Identify current patients prescribed ranitidine injection and review to establish if ongoing treatment is
    still required.
  • If ongoing treatment is still required, then review to see if switching to an alternative oral treatment is appropriate (see table 1 and additional recommendations under the Oral Ranitidine section above for advice on oral alternatives).
  • If ongoing IV treatment is still required, then consider switching to an alternative IV treatment (see table 2 for advice on IV alternatives). There are currently sufficient supplies of IV omeprazole to manage an increase in demand. There are currently no licensed alternative IV H2-receptor antagonists available in the UK.

Prescribers should work in close collaboration with their pharmacists to understand which clinical alternatives are available.

Send enquiries about this notice to the DH Supply Resilience Team supplyresiliencemd@dhsc.gov.uk quoting reference number SDA/2019/005.

For more information on medicines shortages, click here.

To report a medicine shortage, click here.



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