When a generic medicine is granted a licence then the regulatory authority has considered it equally safe and clinically equivalent to the reference branded medicine when used at the same dose to treat the same condition. Many medicines are available in both branded and generic forms, however, the generic medicines are usually much less expensive to the NHS. Prescribers are recommended to prescribe medicines by the approved generic name where possible.
Using the approved generic name is an important part of patient education. In general the approved generic name remains constant and is prominently displayed on the outer packaging, although the actual packaging and appearance of the medicine may change. It is important to recognise that the changing form and appearance of medicines may be an important factor in patient confusion and non-compliance. The practice medicines optimisation pharmacist should bear this in mind, working with the local community pharmacists to ensure that patients remain well informed and the patient medication experience is maintained.
There are a range of situations where the prescriber should work closely with their medicines optimisation pharmacist to decide where branded prescribing may be acceptable. The following are examples:
- Medicines with a narrow therapeutic index. Although there may be limited good quality evidence for any significant clinical difference between bioequivalent medicines, the prescriber may wish to consider prescribing medicines such as certain anticonvulsants (eg phenytoin), immunosuppressant (eg cyclosporine) and lithium by brand.
- Certain modified or extended release products. Firstly the prescriber should consider whether a modified release preparation offers any benefit over an immediate release product. The MHRA recommends prescribing all modified release products by brand. This is particularly important where medicines can be formulated into once daily or twice daily products. Examples include diltiazem, nifedipine, mesalazine and strong opioids. There may, however be significant price differences between particular brands and the prescribers should work with their medicines optimisation pharmacist to produce a preferred list of modified release branded generics.
- Certain administration devices. The MHRA has advised healthcare professionals that CFC-free beclometasone inhalers (Qvar® and Clenil® Modulite) are not interchangeable and should be prescribed by brand name. This may also be important with insulin which is to be used with a specific pen injector.
Multiple ingredient products, where no generic preparation exists and it is common sense to prescribe by brand to ensure correct identification and avoid dispensing mistakes.
- Different licenced indications for the same drug. Occasionally a medicine is marketed under two brands for different conditions. In this situation the prescriber should specify the licensed on-label brand for the condition treated.
There are two other possible situations to consider:
- For conditions requiring long-term medication, differences in appearance between manufacturer’s products might cause confusion and anxiety which may affect adherence. This may be of most concern among the elderly, those with learning disabilities, mental health problems, non-English speaking patients and those with low-levels of ‘health literacy’. The practice medicines optimisation pharmacist should work with local community pharmacists to allay such fears, but in certain circumstances it may be appropriate for a specific brand or a particular manufacturer’s generic to be prescribed
- Inactive formulation ingredients (excipients) may differ between products (branded and generics) and although felt to be rare, where a patient is considered intolerant to an excipient, a specific product could be prescribed.