The Royal Pharmaceutical Society of Great Britain has slammed the government’s proposals for generic substitution, particularly as they essentially oust pharmacists from the decision-making process.

In early January the Department of Health launched a consultation over its plans for automatic generic substitution - whereby a branded medicine is automatically switched for a cheaper, copycat formulation - in a bid to boost generic prescribing from 83% to 88% and thereby save the National Health Service some serious cash.

The DH offered three different scenarios with regard to the future of generic substitution in England: keep the current situation as it is; introduce dispensing flexibility with specific exclusions; and introduce dispensing flexibility but limiting the scheme to only a selected group of products on a select list.

The Department’s preferred approach is the third option but with an opt-out clause so that prescribers can choose to stick with the branded medicine because for reasons such as patient safety or clinical need, but the RPSGB English Pharmacy Board said it does not consider any of the options fully acceptable.

While the Society supports the principle of generic substitution, “under the current proposals there is no opportunity for pharmacists, who are experts in the use of medicines, to be involved in the decision process of when to substitute generically”, explained Howard Duff, Director of England.

In addition, the proposals are “operationally extremely complex” and the EPB has voiced concerns over liability and the potential for misconduct or fraud because of failed communication between healthcare professionals, as well as over the additional workload for pharmacists who will need to understand and explain the process to patients.

The EPB warns that the proposals for generic substitution are “a short term fix and not a long term solution”, which “could harm both pharmacy / patient and pharmacy / GP relationships and that patient care could suffer and that pharmacists could face financial loss”.

EMIG objection
Going one step further, the Ethical Medicines Industry Group has urged the Department of Health not to introduce automatic generic substitution at all, noting that, in a recent survey of its member companies, 85% preferred Option 1 of the consultation – ie keep the situation as it is – as this is least likely to compromise patient safety.

According to the EMIG, automatic generic substitution will expose patients currently prescribed branded products for specific conditions to “unnecessary additional risks for little or no clinical benefit,” and it pointed out that in a recent poll by the majority of doctors - 76% - were opposed to the principle.

In addition, it warned that the policy could diminish incremental innovation, reducing the drive to improve products via better delivery mechanisms or fewer side effects, which can also offer significant benefits to both the patient and the NHS.

“The introduction of generic substitution has faced opposition from patients, professionals and industry,” remarked Leslie Galloway, Chairman of EMIG, and he said: “We hope the Department will listen to our concerns and abandon its proposals to implement this costly and unwanted system”.