Generic Substitution

Discussions taking place — DDA Online looks at the issues

Dr Allan Tennant reports

17^th of April 2009

In reply to a recent written question on generic substitution from Earl Howe, Shadow Health Minister in the Lords, Lord Darzi said that:

• Discussions were taking place with key national stakeholders.
• He could not say if there will be a formal consultation.
• The department is currently considering a scheme for generic substitution that would require negative resolution secondary legislation.
• The scheme would not be mandatory
• Provision will be made to allow the prescriber to opt out of substitution where, in his clinical judgment, it is appropriate for the patient to receive a specific branded medicine.

Generic substitution will be introduced in the UK in January 2010. Its primary aim is to reduce costs. The government predict an annual saving of £million by 2013. It was negotiated as part of the PPRS agreement, the government negotiated generic substitution and the manufacturers will receive government help in encouraging the uptake of new medications.

Generic substitution is different to generic prescribing. It means that a pharmacist could substitute a generic drug on a prescription of a brand without consultation with the patient or the doctor who wrote the prescription, unless a doctor ticks a box to insist on the branded drug.

Currently generic substitution is not allowed by UK law except in emergencies.

Most doctors in the UK are already prescribing generically. In my PCT, where a significant number of doctors dispense, for February 2009 the generic prescribing rate was 86% and the national figure is 84%. My practice which spends a great deal of effort ensuring generic prescribing can only reach slightly higher at 89%. The majority of my patients are happy with generics.

Which products remain as branded prescriptions are:

• Products which are recommended to be prescribed as a brand, where bio-availability of the drug varies between brands. These include:
• Drugs with a narrow therapeutic index.
• Some modified release preparations.
• Modified release opiates
• Some inhalers
• Multi ingredient products, for example combined oral contraceptives.
• Insulins, depot injections, vaccines, stoma products, nutrition and nicotine replacement therapy.
• That small number of patients who insist on a brand because of problems with a generic.
• Products which when prescribed generically cause more problems, such as combined oral contraceptive pills. We found that the different combinations of generic oestrogens and progestogens caused confusion for doctors, dispensers and patients.
• Some PCTs now try to insist that some GPs prescribing certain high volume generics as brands when it is cheaper than the generic.
• Prescribing by brand in error.

Problems with generic substitution:

• When patients are switched from brand to generic, the colour and shape will cause confusion. Many patients recognise their medication not by its name but by the physical characteristics of the pill or capsule. The will also be a change in packaging.
• The generic supplied by the pharmacist or dispensing doctor can change from month to month with the problems incurred as above.
• Most medications are prescribed to the elderly who now experience levels of polypharmacy never seen before. They can become confused about their medication and this may result in non compliance.
• An alteration to a doctor’s prescription by someone else can interfere in the doctor patient relationship. The perceived correction of the prescription may cause the patient to question the doctor’s competence. Another factor affecting the relationship maybe that the patient may perceive that the doctor has given them a cheaper, inferior alternative.
• If the wrong drugs are substituted, such as anti epileptics it can result in increased hospitalisation.
• Just as a doctor can prescribe a brand in error (which one could argue is unlikely to affect patient safety), a new error will be introduced of inadvertently failing to tick the “keep as a brand box”.
• Substitution errors by pharmacists.
• Inappropriate substitution.
• If an error occurs or harm befalls a patient following generic substitution, who is responsible? The prescriber or the generic substituter.

As Dispensing Doctors we probably have more insight into the potential problems than people who just dispense or just prescribe.

A recent PJ Online article Will generic substitution create a new industry relationship? discussed the commercial benefits to pharmacists of them gaining the ability to generic substitute and the change in the industry-pharmacists relationship. Suggesting that there would be indirect benefits to pharmacy of companies encouraging the use of their particular generics by pharmacists.

There will be some cost savings as a result; however as the UK already has a very high generic prescribing rate the savings from generic substitution maybe less than its introduction in other countries. Some commentators think the government is unlikely to meet its 2013 target of 0.9% reduction in costs. (see Healthcare Republic )

To protect patients through the change:

• A robust list of products that should not be changed must be produced.
• Patient education by GPs is paramount.
• The government must provide suitable educational materials for patients.
• The GP software suppliers will need to produce a simple prompt for doctors to tick the box to keep products as brands, where required for patient choice or safety.

I presume that pharmacists will be paid to perform this new service as an enhanced service; I have not been able to find costings on generic substitution. Obviously those PCTs which have in place GP incentives to prescribe generically will withdraw these.

DDA Concerns

Finally we come to the thin edge of the wedge. The DDA has concerns that generic substitution could be the first step on the road to “therapeutic substitution” i.e. switching between different drugs of the same therapeutic group or between drugs in the same therapeutic class. Proposals of this sort were made in the Pharmacy White Paper.

Secondly the minister says the scheme will not be mandatory, however the DDA is concerned that PCT interpretation of central guidance is to impose the guidance as if it were mandatory.

Thirdly, the DDA believes that because of the potential risks to patients this important issue needs wider public consultation, rather than the more limited, “discussions with key national stakeholders.”

Resources

Drugs which should not be prescribed generically

APBI Generic Substitution

Generic substitution: Specific Disease examples

BMJ News article Generic substitution of drugs to be introduced in 2010 BMJ 2008;337:a2699

First published by Dispensing Doctors Association Online.

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Last updated: 16 December 2009

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