Background Autologous serum eye drops (ASED) have been reported to be effective in the management of ocular surface disorders, such as dry eye syndrome and following ocular surface reconstruction. Under Spanish law, ASED are considered a drug, and in our hospital the pharmacy service is responsible for their preparation.
Purpose To describe the use, preparation and clinical effectiveness of ASED prepared by a hospital pharmacy service.
Material and methods Retrospective observational study. Sample: 100% patients. Data sources: electronic medical records (IANUS application) and pharmaceutical records.
Analysed data: number of patients, age, sex, diagnosis, ASED concentration, treatment time, microbiological controls of the final product, serological controls (HBV, HCV, HIV, syphilis) and clinical evolution.
Preparation protocol: sterile phlebotomy of patient blood, allow clotting for 2 h at room temperature, centrifuge for 10 mi at 2000 rpm, dilute from 20% to 50% with normal saline using a sterilising filter (0.2 μm) and divide into 5–7 mL portions in sterile bottles. Check for microbiological contamination: if negative, hand out to patient and if positive do not give to patient. Check for serological controls: if positive, prevent patient from using ASED. Store frozen ASED for 3 months at -20°C. Use new bottle weekly and store at 2–8°C.
Results 70 patients. Age 65 (29–93) years, 46 women (65.7%). Diagnosis (number of patients): persistent epithelial defects (26); severe dry eye (24); neurotrophic keratopathy (6); Sjögren syndrome (4); superior limbic keratoconjunctivitis (1); and amniotic membrane transplantation (1). ASED prescribed concentration (number of patients): 20% (49); 30% (10); 40% (1); and 50% (10). Treatment time (number of patients): 1 year or more (28); 6 months to 1 year (26); and <6 months (16). Microbiological controls: 121 (0 samples positive). Serological controls: 86 (1 patient positive for syphilis). This positive patient was excluded and treated with doxicicline.
Usual doses: 3–4 times/day. Clinical evolution (number of patients): improvement (29); stabilisation (2); no improvement detected (38).
Conclusion ASED are useful for the treatment of severe dry eye pathologies but in these patients clinical improvement was only registered in 42%. We believe it is necessary to do intensive and long term patient follow-up. When ASED were compounded using an aseptic technique, no microbial contamination was detected.
References and/or Acknowledgements
Reed, Kane Carlson, et al. Int J Pharm Comp 2009;13:540-3
References and/or AcknowledgementsNo conflict of interest.
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