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The Cytotoxic Drug Reconstitution (CDR)

1.    Introduction 

2.     Objective

        To prepare all cytotoxic drug doses aseptically where all precautions will be taken to ensure the sterility
        of the products and to minimize staff exposure to these agents.
 

3.    Quality Assurance
 

        Parenteral cytotoxic drugs are reconstituted in Class10,000 Vertical Laminar Airflow Hood (Cytogard) which is designed  to provide an environment which is free from bacteria contamination and protect the operator from exposure to aerosols.  Validation of both cytogard and clean room is carried out once a year. Routine basic microbiological monitoring using passive agar plate is  done weekly.

Proper documentation, labeling and  safe handling of the drugs are emphasized in this service. Personnel are trained to ensure strict aseptic technique during compounding to maintain the sterility of the product and avoid spillage of the product. Education and training has been carried out through the year for the staff.

Proper disposal of waste materials is handled by the Hospital Support Service.

4.    Achievement
 

Year
Reconstituted doses
1991 49
1992 77
1993 47
1994 111
1995 180
1996 438
1997 801
1998 1500
1999 1417
2000 2060
2001 2238
2002 2813
2003  
  

QAP Indicator

Proportion of CDR requests/ prescriptions compounded by the scheduled date to total no. of requests received. (Standard not less than 90%).

For 2002, our achievement was 100%.

 

5.     Plans for 2003

        5.1    Target :   No. of doses to be reconstituted: Min. of 2,500 doses .

        5.2   Medical check-up for staff who is involved in preparing CDR.

        5.3   To improve the safety aspects of the CDR room.