NKF Campaigns Zone:
Government & Parliament

Petition for Public consultation on Generic Substitution

A report: Automatic Generic Substitution — Clinical Implications for Patients published on 16 July, endorsed by a multidisciplinary group of healthcare professionals and patient groups, is calling for the Department of Health (DH) to hold a public consultation over the proposal for Automatic Generic Substitution, whereby in January 2010 the prescriber would lose the power to decide what medicine their patients ultimately receive.

The report has been developed from interviews with healthcare providers, patient associations and published literature, and drafted by a medical writer funded by Norgine. All signatories have fully and independently agreed and endorsed the content. It is vital that the voices of patient groups and patients are also heard. We encourage you to visit http://petitions.number10.gov.uk/genericsubst/ to add your name to the list of stakeholders calling the DH to hold a public consultation to consider two key issues: the practical impact of generic substitution on patients’ adherence and outcomes; and the potential impact of varying bioavailability on outcomes and adverse events.

Patient safety is at the core of all treatment decisions. As the prescriber knows the patient’s medical history, it should be at their discretion what medicine the patient is prescribed. Although it is indicated that prescribers will have the option to prevent substitution on each prescription item by use of a ‘tick-box’, the report raises concerns that this might not be adequate to safeguard patients.

Mary Baker, President of the European Federation of Neurological Associations (EFNA) commented: ‘We are aware of patient concerns surrounding Automatic Generic Substitution and hope that the DH will give careful consideration to these in the consultation process.’

While generic medicines have the same active ingredient as the branded medicine, they are not always identical to the branded medicine, which could mean a patient may receive a medicine that is less effective or has different side-effects, or that may disrupt the management of a chronic disease. It is important to remember that generic substitution can also lead to switches between generic medicines. Generic medicines often have different sizes, shapes, colours and packaging to each other, and to the branded medicine.¹  On each visit to the pharmacy a patient could receive medication with a different appearance. Switching between medications has been shown to significantly reduce adherence to treatment² and it is known that poor adherence is associated with worse outcomes and increased costs for a variety of conditions.^3,4 These problems are exacerbated in elderly patients, who are more likely to be taking multiple medications.¹

The Association of the British Pharmaceutical Industry (ABPI) has suggested that if generic substitution is introduced certain classes of medication will be exempt; for example Narrow Therapeutic Index (NTI) medications, biologicals and biosimilars, controlled medicines, and modified and sustained release preparations. However, there are many conditions where Automatic Generic Substitution could be detrimental to the patient’s health. It is known that many medicines have the potential to interact with each other. For example, patients treated with NTI medicines may also receive other non-exempt medicines. Theoretically a pharmacist could switch a concomitant medication from one generic to another and alter the effects of the NTI medicine. This could be a particular issue for the elderly, who often have multiple conditions and receive multiple medications. A study of patients registered at 201 UK general practices conducted in 2005 showed that patients aged 65-69 years received repeat prescriptions for an average of six medications.⁵

The NKF’s View

The NKF takes the view that for Long Term conditions (such as our members have), different rules should apply and the prescriber should remain in control.

Sign the Petition for a Public Consultation on the Number 10 website.

References

¹ Royal College of Physicians. Patients, physicians, the pharmaceutical industry and the NHS. February 2009.

² Thiebaud P, patel BV, Nichol MB, Berenbeim DM. The effect of switching on compliance and persistence: the case of statin treatment, Am J Manag Care 2005; 11: 670-674.

³ Bainbridge JL, Ruscin JM. Challenges of treatment adherence in older patients with Parkinson's disease. Drugs Aging. 2009; 26: 145-155.

⁴ Ansell BJ. Not getting to goal: the clinical costs of noncompliance. J Manag Care Medicine 2008; 14: 9-15.

⁵ Carey IM, De Wilde S, Harris T, Victor C, Richards N, Hilton SR, Cook DG. What factors predict potentially inappropriate primary care prescribing in older people? Analysis of UK primary care patient record database. Drugs Aging 2008; 25: 693-706.