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HoC Answers - 01.02.10
Generic Substitution
Mr. Hoyle (Labour, Chorley): To ask the Secretary of State for Health (1) if he will issue guidance on liability in cases where a drug automatically generically substituted by a pharmacist adversely affects a patient and that patient's GP has not informed the pharmacist that such adverse effects are likely;
Mr. Hoyle: (2) what assessment has been made of the effect of implementation of proposals for automatic generic substitution of medicines on the workload of (a) clinicians, (b) pharmacists, (c) nurse prescribers and (d) other health professionals; and if he will make a statement.
Mr. Mike O'Brien (Minister of State for Health Services): In developing the proposals and analysis set out in the consultation document "The proposals to implement 'Generic Substitution' in primary care, further to the Pharmaceutical Price Regulation Scheme (PPRS) 2009" and its associated partial impact assessment, published on 5 January 2010, the Department was informed by information from stakeholders, including concerns relating to liability. Under the Department's preferred approach (option 3), there are mechanisms for ensuring that patients continue to receive the most appropriate treatment.
Therefore, we believe the liability risks associated with the proposed generic substitution arrangements should not be any greater than under current prescribing and dispensing arrangements. The Department has not issued guidance on liability for prescribing and does not anticipate that such a need will arise under the generic substitution arrangements.
The Department's assessment of the overall effect of implementation on the workload of health professionals is set out in the accompanying partial impact assessment.
We recognise that further evidence may be available in relation to both liability and impact on health professionals' workload, which is why we are holding a full public consultation, to which all those with an interest can input, including patients. The consultation document and partial impact assessment can be found on the Department's website at: www.dh.gov.uk/en/consultations/index.htm.
Posted 1 February 2010