Background The normal supply of Caelyx was interrupted worldwide in December 2011. Because of the limited number of vials available, medicines agencies established a plan to control the distribution and use, restricting it only to patients with advanced ovarian cancer on second-line treatment and Kaposi’s sarcoma associated with AIDS.
Purpose To assess the Caelyx prescription profile and how the alert has affected the off-label use of this drug.
Material and methods A retrospective observational study was performed of Caelyx prescriptions. Data were collected from the oncologic electronic prescription program by reviewing the patients’ medical history. We set break points for data collection when the shortage and the re-establishment of the supply alerts were published (December 2011 and October 2012, respectively). Variables included: total of patients, diagnosis, off-label uses and the number of treatments initiated before and after the alerts were published.
Results Forty-nine patients have been treated with Caelyx since marketing authorisation. Before the alert was published, 32 patients had been treated. Diagnoses were: Kaposi’s sarcoma (2), ovarian (12), breast (13) cancers and multiple myeloma (1) plus four off-label uses (endometrial (1) cancer, Hodgkin’s lymphoma (2), malignant fibrous histiocytoma (1)).
From the shortage alert publication until the re-establishment of the supply, six patients were treated for authorised indications. Diagnoses were: ovarian cancer (5) and Kaposi’s sarcoma (1).
After the re-establishment of the supply, 11 patients were treated. Diagnoses were: Kaposi’s sarcoma (1), ovarian (5) and breast (4) cancer and one patient with endometrial cancer on off-label use.
Off-label uses approved decreased from four before the shortage alert to one after the re-establishment of the supply.
Excluding the stock-out period, the number of patients whose treatments were initiated before and after the re-establishment of the supply was reduced by 66%.
Conclusion The shortage of Caelyx has changed the prescription profile. Currently, less Caelyx is being prescribed and the clinical practice is more consistent with the Summary of Product Characteristics.
References and/or Acknowledgements No conflict of interest.
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