Following repeated MHRA Class 2 Medicines Recalls, there has been a significant supply shortage of ranitidine within the UK since 2019.
Ranitidine, a histamine 2 receptor antagonist (H2RA), is primarily indicated and licensed for gastrointestinal conditions. Due to the recall, patients have had their treatment changed. The Clinical Commissioning Group (CCG) had driven the switch of ranitidine to alternative treatments. This policy focused on initiating proton pump inhibitors (PPI) or dose optimising existing PPI therapy.
We sought to evaluate the clinical outcome after switching patients from their established ranitidine treatment to suitable alternatives, following the CCG switching guidance.
A pharmacy stock management database generated a list of all ranitidine supplied to adult (18 years or over) admitted to any medical ward during 2019. The record was analysed to include only patients who met the audit inclusion criteria and had been prescribed ranitidine prior to admission. The audit questionnaire was validated by the audit team.
Patients were interviewed and contacted by telephone in November 2020. The data collection and interviews were conducted by the same person throughout the audit. A total of 53 patients were contacted by telephone, with consent obtained in the first instance of the call. These patients had a minimum of 10 months post-switch implementation guideline before the audit was conducted.
Patients were asked a series of closed questions enabling self-evaluation on the clinical effectiveness prior to, and post, ranitidine treatment switches. The focus was on perceived symptom changes and symptom frequency. Quantitative data was collected from the patient sample and summarised statistically to enable recognition of patterns, connections or relationships.
Over half of patients felt symptoms had improved and a quarter experienced no difference
Results showed that sixty percent (n=32) of patients were switched to a PPI, nearly one-fifth (18.5 percent; n=10) stopped therapy, and a small minority (7.5 percent; n=4) were switched to an alternative H2RA or liquid antacid respectively.
Less than five percent of patients were treated with combined options, such as alginate and PPI or H2RA alternative and PPI. No patients were referred to a specialist.
Over half (57 percent; n=30) of patients felt symptoms had improved, a quarter (25 percent; n=13) experienced no difference, and nearly one-fifth (19 percent; n=10) felt their symptoms had worsened following the change to their treatment.
The largest improvement was observed in those switched to a PPI; however, all those who felt they had improved still experienced symptoms.
This study involved a small cohort of patients, and there is the possibility that patients lacked understanding of the drug switch and found it difficult to remember their symptoms before the switch when the interview was conducted. However, this study has demonstrated that further exploratory work is required to evaluate CCG guidance to include the referral pathway for treatment failure and establish a follow up guideline to optimise treatment across NHS clinical practice and patients’ quality of care.
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Competing interest statement:
The author declares: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.