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house of commonsJanuary 27 2016

Generic substitution, where the pharmacist can dispense a generic product when a branded medicine has been prescribed, seems unlikely to be introduced into community pharmacy.

Although “generic substitution has happened in secondary care for many years”, Life Sciences Minister George Freeman gave no indication in a written answer that it would be introduced into the community sector. Instead, Mr Freeman noted: “The Department consulted on introducing primary care generic substitution in 2010, but did not progress the proposals following concerns about the potential impact on patient safety.

“Most general practitioner practices and clinical commissioning groups have been pursuing and supporting policies of increasing generic prescribing for 15 years or more. Generic prescribing rates are already relatively high in England at 84.1% in 2014.”

Mr Freeman was responding to a number of written questions by Sir Kevin Barron, MP for Rother Valley and also Chair of the All Party Pharmacy Group. Sir Kevin had asked what steps were being taken to substitute the prescribing of high volume branded medicine with generic equivalents.

He also asked what estimate had been made of the potential annual savings to the NHS through greater generic substitution compared to using their reference originator products, and what assessment had been made of the obstacles to implementing generic substitution for inhalers, and biologics and other complex products.

Mr Freeman said that the Government has made no such assessments, repeating that England has one of the highest levels of generic prescribing in Europe. “Prescribers are ultimately responsible for their own prescribing decisions. We expect them to always satisfy themselves that the medicines they consider appropriate for their patients can be safely prescribed and that patients are adequately monitored.”

In a third question, Sir Kevin asked whether there had been any discussions with the medicines regulator, the MHRA, about the requirement for some generic medicines to be given a brand name for clinical reasons, and what steps had been taken to ensure patients receive the brand name medicine specified.

Mr Freeman said: “The responsibility for prescribing rests with the practitioner who has clinical responsibility for their patient's care and we would expect practitioners to take any relevant guidance into account when making their prescribing decisions. Prescribers utilise a wide range of information to inform their prescribing decisions including decision support systems and authoritative guidance such as that from the MHRA, the National Institute for Health and Care Excellence and the British National Formulary.

“In primary care, if it is clinically appropriate for an individual patient to be maintained on a specific manufacturer’s product then the prescriber can specify this on the prescription for that product to be dispensed. Officials from the Department and MHRA liaise as required on the application of this policy.”

Links:

House of Commons written question - generic substitution

House of Commons written question - potential savings

House of Commons written question - branded generics

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