Intended for healthcare professionals


Health department consults on automatic substitution of generics

BMJ 2010; 340 doi: (Published 08 January 2010) Cite this as: BMJ 2010;340:c135
  1. Susan Mayor
  1. 1London

    England’s Department of Health has launched a consultation on proposals for automatic generic substitution, in which pharmacists could dispense generic forms of drugs instead of branded versions even if the prescribing doctor or nurse has written a prescription for a brand.

    The consultation report outlines three options. The first is to keep the current arrangements, in which pharmacists are required to dispense exactly what is written on a prescription and cannot substitute a generic version for a brand name drug without prior agreement with the prescriber. The second would allow substitution of generic equivalents but would specify a list of exempt products. The third option, preferred by the health department, would allow generic substitution of a specified group of products.

    Under the third option all prescriptions would be dispensed as written except for the products on a list, which the report argues could be kept short by focusing on drugs that would give the greatest financial savings. The list would include commonly prescribed drugs, drugs that have recently come off patent, and drugs that are often prescribed as branded products. A draft list of 40 drugs includes a range of commonly used antibiotics, ß blockers, statins, and non-steroidal anti-inflammatory drugs.

    The report says, “On balance option 3 best meets the objectives of continued prescriber autonomy to meet clinical need and maintain patient safety, increased financial efficiency, and a manageable increase in workload for prescribers and dispensers.”

    It notes that whichever option is chosen, health professionals would retain final control over what is dispensed by being able to stipulate where generic drugs should not be substituted because of a patient’s particular medical needs. This will be achieved by an “opt-in” system, in which a prescriber indicates whether dispensing of a generic drug is acceptable, or an “opt-out” system, in which the prescriber would indicate that a generic equivalent is not acceptable. The health department prefers the opt-out option.

    Plans to introduce generic substitution in primary care were outlined in the 2009 update of the Pharmaceutical Price Regulation Scheme, a five year voluntary agreement between the health department and the drug industry to control prices of branded drugs. The aim of the proposal, together with other drug price reductions, is to reduce spending on branded drugs by an average of 5% a year from the current UK total of £9bn (€10.1bn; $14.4bn) a year.

    Steve Field, chairman of the Royal College of General Practitioners, said, “The Royal College of General Practitioners supports the prescription of generic medicines, where appropriate, and has promoted this for many years. We support the consultations because we know that the vast majority of GPs would agree that the prescription of generic drugs ultimately saves money for the NHS, whilst not reducing the quality of care provided. Any money saved, of course, can be redistributed.” He noted that some drugs must continue to be prescribed under trade names, because bioavailabilty may differ between branded and generic forms.

    Bill Beeby, chairman of the clinical and prescribing subcommittee of the BMA’s General Practitioners Committee, said, “The UK already has very high usage of generic products, so this is only going to affect a small percentage of patients’ prescriptions, possibly less than one in 100.

    “There are difficulties involved in introducing the substitution of generic drugs for branded products, and for this to work there will need to be changes to prescription forms and computer systems.

    “The emphasis must be on patient safety and minimising the chances for errors. There are certain patient groups, for example those with epilepsy, where changes in medication could have serious consequences. The proposal to target specific drugs where these risks are not present recognises those concerns, but it is still unlikely to be an easy process and may not be the best way to achieve the desired cost savings.”

    The consultation will close on 30 March.


    Cite this as: BMJ 2010;340:c135


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