Drug utilisation and off-label use of medications in anaesthesia in surgical wards of a teaching hospital

Abstract

Background and Aims: When a drug is used in a way that is different from that described in regulatory body approved drug label, it is said to be ′off label use′. Perioperative phase is sensitive from the point of view of patient safety and off-label drug use in this setup can prove to be hazardous to patient. Hence, it was planned to assess the pattern of drug utilisation and off-label use of perioperative medication during anaesthesia. Methods: Preoperatively, demographic details and adverse events check list were filled from a total of 400 patients from general surgery, paediatric surgery and orthopaedics departments scheduled to undergo surgery. The perioperative assessment form was assessed to record all prescriptions followed by refilling of adverse events checklist in case record form. World Health Organization (WHO) prescribing indicators were used for analysis of drug utilisation data. National Formulary of India 2011 was used as reference material to decide off-label drug use in majority instances along with package insert. Results: A total of 3705 drugs were prescribed to the 400 participants and average number of drugs per patient was 9.26 ± 3.33. Prescriptions by generic name were 68.07% whereas 85.3% drugs were prescribed from hospital schedule. Off-label drugs overall formed 20.19% of the drugs prescribed. At least one off-label drug was prescribed to 82.5% of patients. Inappropriate dose was the most common form of off-label use. There was 1.6 times greater risk of occurrence of adverse events associated with the use of off-label drugs. Conclusion: Prescription indicators were WHO compliant. Off-label drug use was practiced in anaesthesia department with questionable clinical justification in some instances.

Keywords

• Adverse events
• anaesthesia
• drug utilisation
• off-label
• National Formulary of India