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Generic Substitution

Consultation published

Dr Allan Tennant reports

7th of January 2010

 

The government published The proposals to implement 'generic substitution' in primary care, further to the Pharmaceutical Price Regulation Scheme (PPRS) 2009 on the 5th of January 2010.

Click link for consultation, questions to be answered and reply form.

Three options are proposed for generic substitution.

  1. No changes and no generic substitution.

  2. Introduce dispensing flexibility but with specific exclusions, so that the arrangements do not apply to a selected group of products on an exempt list.

  3. Introduce dispensing flexibility but limiting the scheme in such a way that the arrangements only apply to a selected group of products on a select list.

Options (2) and (3) also both need to give prescribers the ability to apply their clinical autonomy to tailor prescribing to their individual patients' clinical needs. This could be achieved by the prescriber either ‘opting in' or ‘opting out' the prescription from the arrangements, which in turn could be implemented by either a tick box system or an endorsement applied by the prescriber to the prescription. It appears quite complicated.

 

Option 3 is the preferred government choice.

 

The government wants to substitute the 5% of drugs that are prescribed as a brand but where a generic is available.

The department seems to have a new term, "Dispensing flexibility" which they describe as prescribing generically provide dispensers with greater flexibility on the products they dispense to patients so patients may obtain their medicines more quickly and less stock has to be held by the pharmacy (which in turn leads to savings for the NHS).

I would suggest that the number of people who have to wait to obtain a specific brand is small and I am unaware of a mechanism where by the NHS saves money from pharmacies and dispensing doctors holding less stock.

 

The department identifies many difficulties with option 2, because

  • we would continually have to update our knowledge of exclusions as the list of exclusions changed.

  • It would require a legal definition of "generic equivalent" that could in practice be very difficult to settle.

  • If substitution were limited to copies of drugs that were identical in all respects to the original, this would be unlikely to achieve the anticipated savings as most generic equivalents are not absolutely identical products. A requirement that the products be identical would also carry with it a risk of the producers of the original version making unnecessary changes to the formulation of their product, simply in an attempt to avoid generic substitution.

  • There is a long history of legal dispute over generic equivalence for the purposes of granting marketing authorisations.

So they want to go with Option 3

This would have a list of products that could be substituted.

The list could be kept short by focussing on the drugs that will yield the biggest financial savings.

The criteria for the list, and any revisions to it, will take account of:

  • the percentage of generic prescribing for the product
  • the ready availability of generic versions
  • whether there are any general clinical or patient safety concerns with regard to interchange between different manufacturer's products
  • the cost savings to be made by allowing generic substitution.

They then list the pros and cons of option 3

The key benefits of this approach are:

  • patients can continue to receive a specific manufacturer's product where their treating clinician judges that there is a clinical need;
  • it ensures value for money is obtained and the savings to the NHS under the 2009 PPRS are maximised;
  • while it will require either new NHS paper prescriptions or system suppliers to add the required wording on the electronic prescription form, the use of the endorsement is a more limited, and more practical, change than the use of a tickbox;
  • the proposed list can be kept manageable and thus more easily recalled by prescribers and dispensers;
  • implementation can be phased so that on the first day of implementation prescribers and dispensers are not required to consider whether a generic can be dispensed for all prescriptions still written as a brand where a generic is available.

The key risks are:

  • the costs of implementation could be disproportionate to the savings;
  • that prescribers may use the opt-out functionality unnecessarily;
  • the difficulty of efficiently maintaining the Select List;
  • the possibility of compromising patient safety:- Paper prescriptions without the additional wording will be circulating in the NHS for some time; for patients this may mean that they may receive a brand when the statement is not on the form, and then a generic when the necessary words are on a subsequent form and then possibly back to brand. One way of mitigating this (but at cost) is to recall prescriptions in use and for all prescriptions from a certain date to contain the required rubric.

Click here for previous Generic Substitution stories at DDA Online and background

The Department is not looking to change primary legislation to effect generic substitution.

 

This consultation is for England only.

 

The consultation closes on the 30th of March 2010.

 

 

 

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