UK Law and Practice Contributed by: Adela Williams, Ewan Townsend, Libby Amos-Stone and Eleri Abreo, Arnold & Porter
8.5 Regulation of Prescriptions and Dispensing by Pharmacies
side the tariff system, and enhanced payments may be made for some patients. In England, most new medicines (and new indica- tions for existing products) and some medical devic- es undergo health technology assessment (HTA) by the National Institute for Health and Care Excellence (NICE), which issues recommendations on NHS use based on its assessment of clinical effectiveness and cost effectiveness. NHS bodies in England are required to make funding available so that patients can access treatments recommended by NICE fol- lowing technology appraisal. NICE assesses other medical devices and diagnostic tests through parallel procedures. NICE HTA recommendations are also followed in Wales. The All Wales Medicines Strategy Group (AWMSG) may issue guidance in Wales on new tech- nologies that have not been assessed by NICE. In Scotland, the Scottish Medicines Consortium (SMC) assesses all new medicines and new indications for existing medicines and issues guidance close to the product launch. In Northern Ireland, its Department of Health (NI DoH), considers NICE guidance and reviews it for legal, policy and financial consequences only, before deciding on implementation. 8.4 Cost-Benefit Analyses In theory, NHS prescribers may prescribe any medi- cine considered clinically appropriate for their patients but, in practice, NHS commissioners control which medicines may be prescribed through local or national formularies, largely determined by the cost-effective- ness of individual products. Treatments recommend- ed by NICE should be included automatically in NHS formularies in England; products not recommended by NICE are generally not funded on a routine basis. An equivalent approach is taken to products recom- mended by the AWMSG, the SMC and the NI DoH.
Community pharmacists purchase products from manufacturers or wholesalers and are reimbursed by the NHSBSA at the rate specified in the Drug Tariff, or, where no reimbursement price is set in the Drug Tariff, at the manufacturer’s list price. When the price paid by the pharmacist is less than that reimbursed by the NHSBSA, the pharmacist makes a margin of profit. The extent of this margin is monitored by the NHSBSA, and claw-backs are imposed to ensure that pharmacy profits do not exceed defined limits. There is no generic substitution by community phar- macists in the UK – the particular product prescribed must be dispensed. However, in general, doctors are encouraged to prescribe products using their inter- national non-proprietary name (INN). Where a prod- uct is prescribed by its INN, the pharmacist may dispense any product that meets the specifications/ INN described, and is likely to select the lowest-cost product. Generic substitution is standard practice in the hospital context.
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