Pharmaceutical Company prosecuted over CoHSH breach



Posted: Sunday, January 16, 2011

by Dale
Ethos Solution Ltd

Swindon pharmaceutical company Catalent Pharma Solutions has been prosecuted after at least 10 employees developed allergic contact dermatitis after working with Olanzapine. Olanzapine is an active ingredient in one of the most commonly prescribed antipsychotic drugs.

The Health and Safety Executive (HSE) prosecuted Catalent U.K Swindon Zydis Limited (trading as Catalent Pharma Solutions) more than 100,000 following the workers development of the irreversible skin disease.

Despite Catalent previously identifying Olanzapine as a potential cause of dermatitis, Swindon magistrates heard that the company failed to complete a review of its CoSHH risk assessment as required by law. However, a complete review only commenced in February 2008 after two cases of allergic contact dermatitis had been confirmed in October and December 2007 and the HSE had visited the premises.

The court heard that during the HSE's investigation a further eight workers were deemed to have allergic contact dermatitis due to exposure to Olanzapine.

"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" HSE Inspector Joanna Knight stated.

Knight continued "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."

A spokesperson for Catalent responded "We deeply regret that ten employees at our Swindon, UK, facility, which employs more than 500 people, experienced adverse dermatologic affects from exposure to one of the ingredients used in the manufacturing process of a medical product. We are working closely with the affected employees to ensure the provision of proper medical care and the appropriate management of their conditions.

"Catalent has fully cooperated with the UK Health and Safety Executive (HSE) and has implemented all recommended engineering and procedural improvements to safeguard our employees' health.

"These actions include significant changes in oversight and monitoring of employee health and safety. The company is now compliant with all relevant health and safety regulations. We regret any duress this incident may have caused to our employees and their families."

Catalent 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), plus one charge under Section 2(1) of the Health & Safety at Work Act 1974.

The company was ordered to pay a fine of 50,000 plus 50,123.10 in costs.

Dale Allen delivers CoSHH compliance as one of the UK's leading compliance authorities. Find out more about how you can use his online COSHH365 CoSHH asssessment tool to produce compliant CoSHH assessments with the benefits of a managed Safety Data Sheet library.
Dale Allen has worked with blue chip companies delivering online compliance solutions for the past 10 years. Dale created Ethos Solution Ltd's flagship product, COSHH365, which provides an online CoSHH assessment tool and managed Safety Data Sheets.

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