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Off-label prescribing in oncology
Susan G Poole1, Michael J Dooley
1Department of Pharmacy, Peter MacCallum Cancer Centre, St Andrews Place, 3002, East Melbourne, Victoria, Australia. Susan.Poole@petermac.org
Summary
Off-label prescribing is common in Australian hospitalized cancer patients, with 22% of prescriptions being off-label or unlicensed. This practice impacts 85% of patients, often involving unapproved dosing or indications.
Area of Science:
- Oncology
- Pharmacology
- Health Services Research
Background:
- Off-label prescribing, using medications outside their approved indications, is prevalent but understudied in hospitalized oncology.
- Limited data exists on the scope of off-label and unlicensed drug use in Australian cancer patients.
Purpose of the Study:
- To quantify the incidence and patterns of off-label and unlicensed prescribing in a hospitalized oncology population in Australia.
Main Methods:
- A prospective audit of medication charts for all inpatients at Peter MacCallum Cancer Centre on a single day.
- Prescriptions were compared against the Therapeutic Goods Administration's approved product information (API) to determine licensing status.
Main Results:
- Of 1351 prescriptions for 130 patients, 22% (293) were off-label or unlicensed.
- 85% of patients (110) received at least one off-label or unlicensed medication.
- Most common reasons included off-label dosing (10%), unapproved indications (9%), and unapproved administration routes (3%).
Conclusions:
- Off-label and unlicensed prescribing is widespread in acute hospitalized oncology settings.
- This practice affects a significant majority of cancer patients, highlighting a need for further investigation and potential guideline development.