Rationalizing the use of auxiliary label for oral oncology drugs

Abstract

Objective

The objective of this study is to develop a systematic approach to standardize the use of auxiliary labels for oral oncology drugs.

Design

The project was multi-phased: environmental scan of auxiliary labels used at six BC Cancer Agency centre pharmacies, develop guidelines to support auxiliary labels standardization, develop inclusion criteria for common warnings and standardize warnings based on guiding principles and evidence (Canadian Compendium of Pharmaceutical Specialties, BC Cancer Agency Cancer Drug Manual, British National Formulary, literature).

Results

Consistent auxiliary labels use was rare (7% of drugs). No explicit methodology for determining previous auxiliary labels use was identified. Guiding principles developed include auxiliary labels supplement counselling and drug-specific patient handouts; a maximum of four auxiliary labels (limited container size and alert fatigue); identify hazardous drugs with auxiliary labels; auxiliary labels not intended for universal warnings (e.g., keep out of reach of children); warnings prioritized by impact on storage, efficacy (e.g., administration instructions), toxicity (including interactions) and other clinical issues. Inclusion criteria were developed for warnings on pregnancy, crushing/chewing, taking with plenty of water, drowsiness/dizziness, alcohol, grapefruit juice, hazardous and sunlight exposure. First list of standardized auxiliary labels was completed in June 2014.

Conclusion

A systematic approach was developed to determine and prioritize auxiliary labels for oral oncology drugs. This has led to a standardized and more accurate labelling throughout the six BC Cancer Agency centres’ pharmacies.