AUTOMATIC GENERIC SUBSTITUTION

Automatic Generic Substitution is a scheme proposed by the Department of Health (DH) whereby pharmacists could be obliged to substitute a generic version (a version of the drug with the same active ingredient) of a medication even if the doctor had written the prescription for a specific brand. While different versions of medicines, either branded or generic, have the same active ingredient, they are not always identical. This means a patient may receive a medicine that is less effective or experience different side-effects, or that may disrupt the management of a chronic disease.

Switches in medications can be confusing for the patient, particularly affecting the elderly and those receiving multiple medications, resulting in reduced adherence to medication.1 Under Automatic Generic Substitution, a patient could receive a different medication, with a different appearance and dosage instructions, on each visit to the pharmacy.

There are many cases where generic prescribing is fully appropriate and vital to containing costs. Indeed, generic prescribing already accounts for 83% of all prescriptions in the UK, a level which has increased significantly over the last number of years.2 Patient safety should be at the core of all treatment decisions. The prescribing doctor or nurse knows the patient’s medical history. Substitutions should not be made without the consent and awareness of the prescribing doctor or nurse.

A CALL TO ACTION

The Department of Health opened a full public consultation on 5th January 2010 on the arrangements for the implementation of Automatic Generic Substitution. This was welcome news due to the many clinical and safety implications that must be considered. Many patient groups and industry bodies responded to the consultation highlighting their concerns. The consultation closed on 30th March 2010 and the DH's outcome is expected in due course.


	"It is already difficult for patients with long-term illnesses or with several conditions to keep up with all the different medicines they have to take each day. Complicating this further by introducing Automatic Generic Substitution could make patients even less likely to take their medicines correctly. The potential risk to the outcomes of thousands of patients is of great concern." Mary Baker President of the European Federation of Neurological Associations (EFNA) and Vice President of the European Brain Council (EBC)

	"I am pleased that the Department of Health is consulting on this issue as there are many significant issues to consider. While generic prescribing is considered an important way to contain costs in the NHS, Automatic Generic Substitution poses risks to patient safety and health outcomes... with little foreseeable gain to the NHS." Professor Trevor M Jones CBE Former Director General, Association of the British Pharmaceutical Industry (ABPI)

Clinical implications for patients

The paper "Automatic Generic Substitution - Clinical implications for patients", written and endorsed by a multidisciplinary group of healthcare professionals and patient groups, examines all areas that must be considered.

This was drafted by a medical writer funded by Norgine. All signatories have fully and independently agreed and endorsed the content.

Consensus paper

'Clinical implications for patients'

Useful resources

Br J Hosp Med

'Losing the right medication for the right patient'

Norgine discussion. There is no Substitute

Norgine discussion piece

'For us, there is No Substitute'

Factsheet

Generic Substitution consultation response uk 2010

Norgine's consultation response

Contacts

Serena Thomson, Burson-Marsteller
Serena.Thomson@bm.com
+44 (0)20 7300 6411

Julie Hornby Winfield, Norgine
JWinfield@norgine.com
+44 (0)1895 826642

References

National Institute for Clinical Excellence. NICE clinical guideline 76: Medicines adherence: Involving patients in decisions about prescribed medicines and supporting adherence. Jan 2009.
National Audit Office. Prescribing costs in primary care. London: The Stationery Office; 2007.

Keywords - Generic Substitution UK, Consultation, Pharmacist, Generic medicine, Prescription

This website is sponsored by Norgine Pharmaceuticals Ltd