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

Patil AE, Shetty YC, Gajbhiye SV, Salgaonkar SV - Indian J Anaesth (2015)

Bottom Line: 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.Inappropriate dose was the most common form of off-label use.Prescription indicators were WHO compliant.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacology and Therapeutics, Seth G.S. Medical College and KEM Hospital, Mumbai, Maharashtra, India.

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.

No MeSH data available.


Related in: MedlinePlus

Percentage distribution of off-label drugs among three major drug classes
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Figure 1: Percentage distribution of off-label drugs among three major drug classes

Mentions: Analysis of prescriptions for off-label drug use [Table 3] revealed that 20.19% of the overall drugs prescribed were off-label. 46.26% off-label drug use was due to inappropriate dose followed by inappropriate indication in 33.29% occasions. Average number of off-label drugs per prescription was 0.62, while average number of off-label drugs per patient was 1.87. Out of total 748 off label drugs, 625 off label drugs were prescribed pre-operatively and average number of off-label drugs per preoperative prescription is 1.56; moreover, 82.5% of patients were prescribed at least one off-label drug. Out of the 346 drugs which were off-label by dose, 63.3% were due to under dosage, while 36.7% were due to over dosage. Out of the 449 off label drugs, 199 were from general surgery department, 150 from pediatric surgery department and 100 from orthopaedics department. Number of off label drugs per patient was 3 in pediatric surgery department. Percentage distribution of off-label drugs is represented in [Figure 1].


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

Patil AE, Shetty YC, Gajbhiye SV, Salgaonkar SV - Indian J Anaesth (2015)

Percentage distribution of off-label drugs among three major drug classes
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4697244&req=5

Figure 1: Percentage distribution of off-label drugs among three major drug classes
Mentions: Analysis of prescriptions for off-label drug use [Table 3] revealed that 20.19% of the overall drugs prescribed were off-label. 46.26% off-label drug use was due to inappropriate dose followed by inappropriate indication in 33.29% occasions. Average number of off-label drugs per prescription was 0.62, while average number of off-label drugs per patient was 1.87. Out of total 748 off label drugs, 625 off label drugs were prescribed pre-operatively and average number of off-label drugs per preoperative prescription is 1.56; moreover, 82.5% of patients were prescribed at least one off-label drug. Out of the 346 drugs which were off-label by dose, 63.3% were due to under dosage, while 36.7% were due to over dosage. Out of the 449 off label drugs, 199 were from general surgery department, 150 from pediatric surgery department and 100 from orthopaedics department. Number of off label drugs per patient was 3 in pediatric surgery department. Percentage distribution of off-label drugs is represented in [Figure 1].

Bottom Line: 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.Inappropriate dose was the most common form of off-label use.Prescription indicators were WHO compliant.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacology and Therapeutics, Seth G.S. Medical College and KEM Hospital, Mumbai, Maharashtra, India.

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.

No MeSH data available.


Related in: MedlinePlus