Current requirements and emerging trends for labelling as a tool for communicating pharmacovigilance findings.
The labelling of prescription drugs is expected to ensure the safe use of medicines and effect changes in use if such changes are required by new safety information. However, withdrawal of drugs from the market and data about medication errors have demonstrated the limitations of labelling as a tool for risk management. Regulatory initiatives in many countries aim at increasing the usefulness and use of labelling by healthcare professionals and patients. These changes in regulations and guidelines, which parallel changes in the approach to premarketing risk assessment and pharmacovigilance, will result in a more relevant and extensive characterisation of a product's safety profile and better international labelling consistency. But despite improvements in the format of labelling in some countries, labelling overall continues to be bound to conventional layout and restricted in its ability to meet the heterogeneous needs of its intended audience. Technological developments such as electronic prescribing and the availability of electronic decision support systems can effectively implement compliance with labelled conditions of use and safety precautions in the prescription process. It will be one of the major challenges to make labelling easily available and suitable for use in such systems. This technology, bar coding of medicines, and preventive evaluation of labelling and packaging for clarity, readability and potential confusion can also help reduce medication errors.
Fontaine
A Leander
AL
Wyeth Research, Collegeville, Pennsylvania, USA.
D002170:Canada; D003142:Communication; D004348:Drug Labeling / Q000331:legislation & jurisprudence / Q000379:methods / Q000592:standards; D005062:European Union; D006801:Humans; D007564:Japan; D008508:Medication Errors / Q000517:prevention & control*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*