§ The Countess of Marasked Her Majesty's Government:
Why there is no entry in the British Pharmacopoeia or the ABPI (Association of British Pharmaceutical Industry) compendium for either carbaryl or malathion based treatments for head lice in humans.
§ The Parliamentary Under-Secretary of State, Department of Health (Baroness Cumberlege):There are monographs for carbaryl (the bulk drug substance) and carbaryl lotion (the preparation used in the treatment of head lice) in the British Pharmacopoeia 1993. These are found on pages 1511 and 1637 of the British Pharmacopoeia 1993, Addendum 1995. A monograph for malathion has been authorised for inclusion in the European Pharmacopoeia and when this is nearing completion monographs for the preparations used in the treatment of head lice will be prepared for inclusion in the British Pharmacopoeia.
The Association of British Pharmaceutical Industry (ABPI) has advised that all data sheets supplied to the ABPI by its member companies are included in the compendium. However, inclusion is voluntary, so in any individual case it is the decision of the company holding the marketing authorisation whether or not to submit a data sheet for inclusion.
§ The Countess of Marasked Her Majesty's Government:
What health surveillance is conducted on children treated with carbaryl, malathion, permethrin and phenothrin products for clearing head lice.
§ Baroness Cumberlege:Health surveillance, which includes developmental checks, is provided by general practitioners and community health service staff for all children up to age five and by the school health service 92WA for children above this age. Suspected adverse reaction reports for human medicinal products are reported to the Committee on Safety of Medicines by the "Yellow Card Scheme".
§ The Countess of Marasked Her Majesty's Government:
Why, when Guidance Note MS17 from the Health and Safety Executive states: "Repeated absorption of small doses [of organophosphates] … has cumulative effects resulting in progressive inhibition of nervous tissue cholinesterase", there are no warnings to users of malathion based head lice preparations about these effects.
§ Baroness Cumberlege:The Health and Safety Executive Guidance Notes refer to the biological monitoring of workers exposed to organophosphorus pesticides. The organophosphate based human medicines for the treatment of head lice infestations are different formulations, used only intermittently at low doses and with limited exposure. The guidance notes are therefore not applicable to human medicines use. Unlike workers exposed to organophosphates, there are no data on serious adverse reactions to human medicines containing malathion.
§ The Countess of Marasked Her Majesty's Government:
What is the level of resistance to carbaryl, malathion, permethrin and phenothrin in human head lice.
§ Baroness Cumberlege:Resistance of human head lice to the available human medicines containing carbaryl, malathion, permethrin and phenothrin varies over time and location, so it is not possible to quantify it. Measures are being taken by local initiatives to rotate treatments over time to avoid development of resistance to the medicines available.
§ The Countess of Marasked Her Majesty's Government:
What research papers have resulted from research conducted specifically into the subtle effects of exposure to malathion, permethrin, phenothrin and carbaryl on the immune and neurological systems of adults, children and human foetuses.
§ Baroness Cumberlege:A number of published papers are available which cover the in-vitro and in-vivo effects in humans of exposure to the listed chemicals and to pesticides generally. These include information about effects on the human foetus.
§ The Countess of Marasked Her Majesty's Government:
What research has been conducted on the extent of use of other organophosphorus products such as flea collars, fly sprays and plant insecticides in households containing young children who have been treated with malathion products for head lice.
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§ Baroness Cumberlege:The potential exposure of children and adults to organophosphates (or any other active ingredient) in flea collars, fly sprays and plant insecticides is considered as part of the licensing or approvals systems. No product would be licensed or approved if, in the view of the expert committees advising the Government, it presented an unacceptable risk to human health. I am unaware of research into the usage of pesticides in family homes.