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Clinical pharmacy and clinical trials (including case series)
The use of mitomycin C in ophthalmic pathologies
  1. R. Rodriguez-Carrero,
  2. O.A. Vergniory,
  3. I. Zapico,
  4. P. Puente
  1. 1Hospital San Agustin, Hospital Pharmacy, Aviles, Spain

Abstract

Background Mitomycin C (MMC) is a drug used in some ophthalmic conditions due to its efficacy, which is supported by the literature. However this is an off-label use, not approved by the European Medicines Agency (EMA).

Purpose To assess the use of MMC in ophthalmic pathologies, describing the pharmacist's involvement in the treatment process.

Materials and methods Retrospective observational study of patients with ophthalmic pathologies treated with MMC during 2009 and 2010 in a regional hospital. Data was gathered by reviewing clinical histories and the validation of the treatments by the pharmacist.

Results Thirty-one patients were treated, 6 were excluded due to lack of information. Of the 25 patients included, 14 (56%) were women. The mean age was 65. Eighty-eight percent (n=22) of the patients presented dacryocystitis and 12% (n=3) neovascular glaucoma. The pharmacist would process the authorisation for the off-label treatment, and MMC would then be reconstituted in vertical flow cabins at a concentration of 0.2 mg/ml; this optimised the use of vials of MMC while providing a sterile preparation. The treatment consisted of a single intraocular dose of 0.2 mg MMC. Treatment was effective in 13 patients (52%), partially effective in 6 (24%) and not effective in 6 (24%). Twelve patients (48%) suffered recurrence, 58% of them during the first six months after treatment.

Conclusions Treatment with MMC in the off-label indication studied was total or partially effective in the majority of the patients, confirming the data in the existing literature. More than half the recurrences took place during the six first months after administration. Collaboration between the ophthalmology and the pharmacy departments in devising a system to speed up patient access to MMC treatment has been a success.

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