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Specials (England/Wales)

  • Wales
  • England

A 'special' is a specially prepared formulation prescribed to meet a patient's individual clinical need, where there is currently no licensed version. For example, a particular strength, a preservative-free formulation or a particular product presentation or form.

Specials should only be prescribed if there is no licensed alternative that is equivalent. If there is a licensed alternative a special should not be prescribed or dispensed. Specials represent only a small percentage of all prescriptions.

Drug Tariff

A number of high cost and high volume specials have now been listed in the Drug Tarff. These specials will be listed under Part VIIIB. However there are others specials not listed in Part VIIIB.

See the Electronic Drug Tariff for details.

Download latest Drug Tariff Part VIIIB.

All specials can be obtained from a specials manufacturer or manufactured by the contractor or 3rd Party (Section 10 exemption of the Medicines Act 1968). However the payment arrangements for 'listed' and 'non-listed' Specials are slightly different. This also includes imported products.

No rebates or discounts

If you do not declare how much discount or rebate you have received on a non-list item then it may be considered as fraud.

No matter how much discount or rebate is directly attributable to the special, this will no longer be paid by BSA.

Payments and sourcing your specials

  • You will only be paid the Part VIIIB price for the special if it is on the list.
  • The DoH expects you to shop around and negotiate lower prices in a similar way to generics.
  • If, under exceptional circumstances, you are unable to source products below Part VIIIB price, you should contact the PSNC and the Numark Information Services team. The PSNC will monitor the situation and apply for an NCSO concession as appropriate.
  • Numark will only recommend the Specials manufacturer that complies with all the necessary regulations and licences.

Endorsing specials

View our specials endorsing guide for details.

For Specials not listed in Part VIIIB, the contractor or his representative will:

  • Stamp, date, initial and endorse the Certificate of Analysis (COA)/ Certificate of Conformity (COC) with the price paid and prescriber's details.
  • At the end of each month send a copy of the COA/COC to the NHS area team of the prescriber along with details of the prescriber, allowing the NHS area team to match expenditure to the special supplied.
  • Other than these differences normal record keeping arrangements will apply with patient details removed.

Patient information

Speak to your GPs and patients/carers about possible differences in taste and/or formulations of specials they might have been receiving.

Expensive items

The PSNC has confirmed that contractors will still get the expensive item fee if the cost of dispensing a Part VIIIB listed item is more than £100. This includes dispensing a Tariff pack size PLUS an extra quantity to meet the prescription amount. Only a single professional fee will be paid. See the PSNC update.

Specials Medicines as 'stock' items

Unlicensed medicines supplied to pharmacies under a 'specials manufacturers licence' or a 'specials importers licence' may be used by the pharmacy to fulfil prescriptions for more than one patient (ie pharmacies can hold them as stock). This has been confirmed by the Medicines and Healthcare products Regulatory Agency, and should help allay some of the cost implications of supplying unlicensed specials due to pharmacies no longer being able to claim broken bulk for these items.

NHS Prescription Services has also confirmed that, if several prescriptions are fulfilled from one single pack of an unlicensed medicine, the new out of pocket endorsement, SP, can be claimed for all those prescriptions dispensed from that pack. This is because the SP endorsement covers additional costs such as contacting the prescriber and not just costs from sourcing the product.

Record keeping

Where an unlicensed medicine is obtained under a "specials manufacturer's licence" or a "specials importers licence" and is issued to several patients, the pharmacy should have a robust record keeping process and ensure that a full audit trail is present for any unlicensed medicines supplied.

For audit purposes, the NHS area team now require copies of the Certificate of Conformity (COC) or Certificate of Analysis (COA) for any non-Part VIIIB unlicensed medicines dispensed. Pharmacies that dispense several prescriptions from one pack will need to retain the original COC or COA with that pack and then take a copy for each prescription dispensed. The copy should be stamped, dated, initialled and endorsed with the price paid, as well as the prescriber details for an individual prescription. This copy should be retained by the pharmacy and a second copy (of the fully endorsed COC or COA) sent to the NHS area team of the prescribing doctor at the end of the month (remember this may not be your own NHS area team).

Section 10 exemption

The situation is not the same for those products manufactured under the Section 10 exemption (extemporaneously prepared either by the pharmacy itself or another provider). These products are made up to meet the needs of a specific patient, and therefore any unlicensed medicines obtained and supplied under this exemption cannot be used to fulfil the clinical needs of several patients.

Imported Specials

The endorsement for imported specials should include the batch number and the Importer's MHRA licence number. Keep any COA/COC that accompanies the imported specials and send to the prescribing GP's NHS area team as appropriate.

 

Advice and updates supplied by Information Services.