ASClock The Blog About Everything!

Review of the Regulation of Head Lice Treatments in Australia

Head lice infestation is a major public health problem throughout Australia, particularlyin rural and remote communities. The cost of head lice infestation in Australia isunknown, but in the USA it has been estimated that the annual cost is US$367 million, including the cost of pediculocides, school absences by infested children, loss of work time by parents required to stay home to treat children, or who become infested themselves, and costs to the school system in trying to deal with the problem (Gratz 1997).

There are a large number of stakeholders with an interest in the regulation of head lice products. These include: The public Manufacturers of head lice products and their organisations Medical practitioners and other health professionals Education departments and school bodies Various government departments including the TGA and NRA / APVMA.

Recently concerns about the regulation of head lice products have been expressed withregard to the following issues in particular: Treatment failures have been reported with commonly used pediculocides, and there are questions about whether these treatment failures are due to resistance developing to these products;

Inappropriate formulations or directions for use may encourage the development of resistance; Questions about the efficacy of products containing low levels of essential oils; Public concerns about the safety of existing products;

Existing guidelines for the labelling of head lice products have been criticised, and there are concerns that these guidelines may be out of date.

For these reasons it was decided by the TGA to engage a consultant to undertake a review of head lice treatments, with the aim of establishing guidelines for packaging and labelling to ensure safe and effective use in the community, to make recommendations on regulatory control (registration or listing), and to advise on the regulatory interface between the TGA and APVMA.

The terms of reference of the consultancy were as follows: To establish evidence based-guidelines for the registration of head lice preparations including appropriate packaging and labelling to ensure safe and effective use in the community. In particular, the following issues should be addressed:

Resistance of head lice to insecticides Directions for use by consumers including contact times and reapplication times The need for efficacy testing on a product by product basis Whether all head lice preparations should require registration as medicines (i.e. head lice treatment be made a “registrable disease”)Whether the regulation of head lice repellents by the APVMA leads to inappropriate treatment in the community

Consultation with relevant stakeholders was part of the process.
Head Lice Treatments, Head Lice Infestation, Head lice Products