Guidance For Appropriate Prescribing Of Generic And Branded Medicines

Guidance for Appropriate Prescribing of Generic and Branded Medicines Version Developed by Ratified by Review date 2.0 Pharmacy and Medicine Optimisation Team, Herts Valleys Clinical Commissioning Group, April 2017 April 2017 (Commissioning Excecutive) April 2020

Guidance for appropriate prescribing of generic and branded medicines 1. Executive summary A generic medicine contains the same quantity of active substance(s) as the proprietary (branded) medicine that originally received marketing authorisation (i.e. the reference medicine). Generic medicines are, overall, much less expensive to the NHS. Their appropriate use instead of branded medicines delivers considerable cost savings. It is good practice to prescribe medicines generically using their approved, International Non-proprietary Name (INN) (i.e. as described in the British National Formulary (BNF)) and not specify the manufacturer or supplier, except where a change to a different manufacturer's product may compromise efficacy or safety. If a generic medicine is granted a license, the regulatory authority has considered it equally safe and clinically equivalent to the branded medicine when used at the same dose to treat the same condition. All generic medicines approved by the regulatory authority have the same quality, strength, purity and stability as branded medicines. The generic manufacturing, packaging, and testing sites must pass the same quality standards as those of branded medicines. However, there are some circumstances in which continuity of the same brand is important for clinical reasons when it is appropriate to prescribe a specific manufacturer's product (branded or generic). Also sometimes manufacturers reduce the price of their branded product to one that is cheaper than the equivalent generic product, so prescribing the branded generic becomes the most cost-effective option for prescribing5 (See section 5 below). This document provides a background on why generic medicines should be prescribed and the circumstances when this is not appropriate. 2. Background The Department of Health continues to support the increased use of generic medicines in a way that is acceptable to patients, recognising that there are still some more cost savings to be made in this area. Presently, if a specific branded drug is prescribed in primary care, a pharmacist is obliged to supply this even if an equivalent generic version is available. Reimbursement is made using the manufacturer's list price for the branded product. When a generic name is written, a branded or generic version can be supplied, but the pharmacist is reimbursed at the generic rate. The switch from branded to generic medicines in appropriate patients has been identified as a potential prescribing efficiency. Data (September 2016) from the NHS Information Services Portal indicates that across Herts Valley CCG the potential annual savings is around 260,000 for drugs that are currently prescribed by brand that could be prescribed generically. Information on potential efficiencies of brand to generic switches has been made available to GP practices for some years, but there remains some reluctance to change certain patients. In order to support practices in making these changes, Herts Valley CCG endorses a position statement available in Appendix 1 supporting the advice in the BNF. Generic and Brand Prescribing Guidance Version: 2 April 2017

The BNF states that “Where non-proprietary (‘generic’) titles are given, they should be used in prescribing. This will enable any suitable product to be dispensed, thereby saving delay to the patient and sometimes expense to the health service. The only exception is where there is a demonstrable difference in clinical effect between each manufacturer's version of the formulation, making it important that the patient should always receive the same brand; in such cases, the brand name or the manufacturer should be stated”1. 3. Scope This guidance applies to all medical and non-medical prescribers commissioned by Herts Valleys Clinical Commissioning Group. This covers the provision of prescriptions to a patient registered on the list of a general medical practitioner, temporary resident or a patient seen within a commissioned service. It does not cover the provision of private services or prescriptions to members of the public who are not registered with the practice. 4. Benefits of generic prescribing Many medicines are available in both generic and branded forms. However, generic medicines are, overall, much less expensive to the NHS. Generic prescribing can reduce the risk of prescribing or dispensing error as each drug has only one approved name, rather than many brand names. Generic prescribing allows patients to recognise the medicine INN on their prescription. This will reduce expectation that a particular brand should be used when a situation occurs where a different product needs to be supplied. Examples of these situations could be patent expiry or a brand becoming unavailable or obtaining supply from a hospital or different dispensary than the patient’s usual one. Where non-proprietary (‘generic’) titles are given, they should be used in prescribing, except in the circumstances detailed in section 5. This will enable any suitable product to be dispensed, thereby saving delay to the patient and sometimes expense to the health service. 5. When a specific manufacturers product should be prescribed A specific manufacturer’s product could be either branded or generic and should be prescribed in the following circumstances: Where there is a difference in bioavailability2 between brands of the same medicine, particularly if the medicine has a narrow therapeutic index. In these circumstances, lack of clarity over which preparation is intended when prescribing can lead to the patient receiving a subtherapeutic or toxic dose. Examples include ciclosporin, lithium and CFC-free beclometasone metered dose inhalers. Generic and Brand Prescribing Guidance Version: 2 April 2017

Where there are important differences in formulation between brands of the same medicine. For example, Fentanyl patches are available as matrix and reservoir formulations. Although neither should be cut, cutting reservoir patches can lead to leaking and overdose so if the prescriber intends the patch to be cut, the prescription must specify a brand of matrix formulation patch3. This also includes certain modified or extended-release products, whereby the drug release and bioavailability profiles may differ considerably, primarily because different formulation approaches have been taken by manufacturers. For example modified-release nifedipine. Certain drug administration devices. Technique may be an important component of drug delivery, and brand name prescribing is appropriate where administration devices, such as metered dose inhalers, have different instructions for use and patient familiarity with the same product is important. For example salbutamol dry powder inhalers and adrenaline prefilled syringes. Multiple ingredient products. Generic titles may not always exist for many multiple ingredient products, and prescribing a specific brand or manufacturer's product is necessary for identification and ensuring that the correct product is dispensed. Examples include: oral contraceptives; emollient creams. Non-proprietary titles should not be invented for the purpose of prescribing generically. Where the product is a biological rather than a chemical entity. A biological medicine is a medicine that contains one or more active substances made by or derived from a biological source. A biosimilar medicine is a biological medicine that is developed to be similar to an existing biological medicine (the ‘reference medicine’). Biosimilars are not the same as generics, which have simpler chemical structures and are considered to be identical to their reference medicines. The active substance of a biosimilar and its reference medicine is fundamentally the same biological substance, though there may be minor differences due to their complex nature and production methods. Examples of biologics with available biosimilars include epoetin alfa and somatropin. Different excipients. Inactive formulation ingredients (excipients) may differ between products (branded and generic). Where an individual patient has a true intolerance to an excipient, it may be reasonable to prescribe a specific brand or generic product that does not contain the troublesome component. Differences in appearance. For conditions requiring long-term medication, differences in appearance between manufacturers’ products might cause confusion and anxiety, and this may affect adherence. This may be of most concern among the elderly, those with learning disabilities, mental health patients, non-English speaking patients and those with low-levels of 'health literacy'. Where it is not possible to allay patients' concerns effectively, it may be appropriate for a specific brand or manufacturer's generic to be prescribed. Recommendations about how healthcare professionals can support patients to adhere to their prescribed medicine can be found in NICE clinical guideline 76. Differences in licensed indications. For example Lyrica (Pfizer) brand of pregabalin has patent protection until July 2017 for its licensed indication of treatment of peripheral and Generic and Brand Prescribing Guidance Version: 2 April 2017