In 2009/2010 the cost to the NHS of specials in primary care was £111m. The cost of the same item can vary ten-fold between different suppliers. This has resulted in PCTs actively monitoring specials activity and costs. In London, specials are part of the Quality, Innovation, Productivity and Prevention (QIPP) primary care work stream. QIPP is a national transformational program designed to implement change in the NHS, improve the quality of care and address the challenge to find £20billion in efficiency savings.
Pharmacists have a key role to play in the provision of specials. There are a number of elements to consider in the supply of specials. Many are initiated in hospital, raising the issue of ongoing care and how the interface works between primary and secondary care.
A proposed model for the provision of specials is summarised in the diagram. The five key stages of the model are:
- Needs assessment
- Generation of prescriptions
- Ethical procurement
- Quality manufacturing
- Delivery to the patient.
As there are increased risks with specials, the first step is to ascertain if the patient really needs a special or if an alternative licensed medicine is available that meets the clinical need of the patient. For example, a different drug in the same class, or a different formulation or availability of a licensed medicine that can be used outside the terms of its license, ie ‘off label’. A needs assessment, including a full clinical review of the patient’s drug regime is required to answer these questions. This review could be carried out by a hospital clinical pharmacist, a PCT prescribing advisor, community pharmacist, a private provider, or a GP. It could be undertaken in an acute care setting, a community pharmacy, community-based clinic or care home, a GP surgery or in the patient’s home. There are several reference sources and published lists of alternatives to specials. These can be referred to when a prescription is presented for a special and the prescriber advised that there is an alternative medicine available.
Once the needs assessment is complete the medicine needs to be prescribed or the prescribing doctor advised of an alternative intervention. The prescription could be written by a prescribing pharmacist at an acute trust, a PCT Team or community pharmacy, a Private Provider, or a GP or Hospital Doctor. Issues that need to be addressed at this point are whether the prescriber is aware that they have prescribed a special and that it is an unlicensed medicine, and the responsibilities and costs which go along with that. Prescribers are accountable for the special unless it can be shown that the medicine is faulty or was not made to the approved specification. The prescriber also needs to ensure that the patient is aware that they have been prescribed an unlicensed medicine and the reasons why.
Specials are often initiated in hospital. When the patient is discharged, responsibility for prescribing often moves to primary care. Good communication between the secondary and primary care teams is required to ensure continuity of care in relation to the review of the need for the medicine and consistency of the special product, as that may vary between manufacturers.
As pharmacists ordering and procuring specials we are jointly responsible with the prescriber for the specification of the product. Ethical procurement is a key role of pharmacists. We need to be monitoring suppliers to ensure that quality products are procured that offer value for money. There are different models that can be used for procurement, such as an acute trust procurement department, community pharmacy or a homecare provider. When procuring a special, it is good practice to request the product specification as the purchaser is agreeing that this is of a suitable quality.
Quality manufacturing is an essential element of the supply chain. The links with the manufacturers will be from those procuring the specials. As these medicines are unlicensed they are not subject to the same regulatory scrutiny as licensed medicines. They can be made under a specials licence or under section 10 exemption. In the hierarchy of risks, products made under a specials licence will be subject to more controls than those made under section 10 and is therefore the preferred option. Suppliers can be either NHS hospital units or commercial specials manufacturers. The way in which the product is made will differ between manufacturers. Some will crush tablets and some will use the active pharmaceutical ingredient to make the product. Some products will be made as batches with more testing and others as single items. A key issue is the stability of the product and this requires the manufacturer to have data to back up the stability given to the finished product. The prescriber and procurer are responsible for agreeing the specification of the product and are therefore taking responsibility for the assigned shelf life.
Currently, there is no rationalisation of products available. Prescriptions are written for a variety of strengths of the same drug. Yet if this was to be rationalised and a single strength made available, there are quality benefits due to the opportunity to batch manufacture higher product volumes, better stability data and better availability. This is a big change in practice and has many advantages. It will need collaboration between primary and secondary care in each locality or alternatively to be addressed nationally by the Department of Health.
Delivery to the patient
The majority of specials prescribed will need to be specially ordered for the patient, so delivery to the patient is a key consideration. Options available are that the patient comes back to the community pharmacy, it is delivered by post or via a home care provider.
There are different ways of bringing these elements together into a service model which offers opportunities for new ways of working between pharmacists and GPs and primary and secondary care. Three different approaches that can be used are:
- Through a commissioned service wholly via an acute trust with a local tariff;
- Commissioned via community pharmacists under a local enhanced service;
- Commissioned via a GP.
Each element of the service could be provided in a different way, i.e. a mix and match approach for each element utilising appropriate expertise to ensure the best model of care for patients. For example, once commissioned, in some areas it may be appropriate to use home care providers for the whole service. In other areas community pharmacies may provide the service either in its entirety or in collaboration with an acute trust and homecare provider for delivery. SLAs could be set up between providers and suppliers to ensure that the service is specified and monitored. To implement this proposed model will bring challenges, however the benefits will be a seamless service providing a high quality, cost effective product for the patient and value for money for the NHS.
Director of pharmacy and medicines
Needs assessment – to include full clinical review of medicines / MUR+
1. Hospital clinical pharmacist in acute trust, community-based clinic or care home
2. PCT prescribing advisor in community-based clinic or care home
3. Community pharmacist or private provider in community pharmacy, community-based clinic or care home
4. GP in surgery, community-based clinic or care home
Generation of prescriptions / GP advised on alternative intervention
1. Prescribing pharmacist, acute trust – writes prescription or advises GP to action alternative intervention
2. Prescribing pharmacist, PCT team – writes prescription or advises GP to action alternative intervention
3. Prescribing pharmacist, community pharmacy, or private provider
1. Acute trust procurement department
2. Community pharmacy
3. Homecare provider
Delivery to patient
1. Via homecare provider
2. Delivered by post
3. Through community pharmacist
Possible Funding Models
1. Commissioned via acute trust / private provider – tariff-based
2. Commissioned via community pharmacist – LES
3. Commissioned via GP
1. Medicines and Healthcare Products Regulatory Agency. Guidance note 14. The Supply of Unlicensed Relevant Medicinal Products for Individual Patients.
2. National Prescribing Centre. Prescribing specials: Five guiding principles of prescribers. July 2011
3. Dealing with Specials. Good practice guidance on the procurement and supply of pharmaceutical specials. Pharmacy Professional Royal Pharmaceutical Society, June 2010.
4. NHS East of England and East of England NHS Collaborative Hub. Information and guidance on the prescribing and use of unlicensed pharmaceutical specials. 2010