Pharmaceutical workers exposed to hazardous substance

Date:

17 December 2010

Release No:

833

A Swindon pharmaceutical company has been fined after a number of its employees were sensitised to a potent substance and developed allergic contact dermatitis.

The Health and Safety Executive (HSE) prosecuted Catalent U.K. Swindon Zydis Limited (trading as Catalent Pharma Solutions) after at least ten employees - including John Renicks, John Clifford and Ian Thorne - developed the skin condition when working with Olanzapine. The substance is an active ingredient in one of the most commonly prescribed antipsychotic drugs and is a known cause of allergic contact dermatitis.

While Olanzapine had been identified by the company as the potential cause of previous cases of dermatitis, it failed to carry out an immediate review of its risk assessment as required by law. Instead, a thorough review was only started in February 2008 after two cases of allergic contact dermatitis had been confirmed on 19 October 2007 and 3 December 2007 and HSE had visited the company.

Swindon Magistrates' heard how during HSE's investigation, a further eight employees were confirmed to have allergic contact dermatitis as a result of being in contact with Olanzapine.

HSE inspector, Joanna Knight, said:

"Catalent UK Swindon Zydis failed to address the inadequacies not only in its systems for working with hazardous substances, but also in its systems for health surveillance and keeping health records. This led to a number of employees being exposed to the substance and subsequently developing allergic contact dermatitis.

"This is an uncomfortable and irreversible condition, which can cause the skin to crack and bleed, and could have been completely avoided had Catalent taken the time to review its risk assessment."

Catalent U.K. Swindon Zydis Limited of Frankland Road, Blagrove, Swindon, pleaded guilty to four charges under Regulations 6(3), 7(1), 11(1) and 11(3) of the Control of Substances Hazardous to Health Regulations 2002 (COSHH), as well as one charge under Section 2(1) of the Health & Safety at Work Act 1974. It was ordered to pay a fine of £50,000 plus £50,123.10 in costs.

Notes to editors

1. The Health and Safety Executive (HSE) is Britain's national regulator for workplace health and safety. It aims to reduce death, injury and ill health. It does so through research, information and advice, promoting training, new or revised regulations and codes of practice, and working with local authority partners by inspection, investigation and enforcement.
2. Regulation 6(3) of the Control of Substances Hazardous to Health Regulations 2002 states that: 'The risk assessment shall be reviewed regularly and forthwith if-
   1. there is reason to suspect that the risk assessment is no longer valid;
   2. there has been a significant change in the work to which the risk assessment relates; or
   3. the results of any monitoring carried out in accordance with regulation 10 show it to be necessary.'
3. Regulation 7(1) of the Control of Substances Hazardous to Health Regulations 2002 states that: 'Every employer shall ensure that the exposure of his employees to substances hazardous to health is either prevented or, where this is not reasonably practicable, adequately controlled.'
4. Regulation 11(1) of the Control of Substances Hazardous to Health Regulations 2002 states that: 'Where it is appropriate for the protection of the health of his employees who are, or are liable to be, exposed to a substance hazardous to health, the employer shall ensure that such employees are under suitable health surveillance.'
5. Regulation 11(3) of the Control of Substances Hazardous to Health Regulations 2002 states that: 'The employer shall ensure that a health record, containing particulars approved by the Executive, in respect of each of his employees to whom paragraph (1) applies, is made and maintained and that that record or a copy thereof is kept available in a suitable form for at least 40 years from the date of the last entry made in it.'

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Issued on behalf of the Health and Safety Executive by COI News and PR (South West)