Unlicensed specials and imports

Unlicensed specials and imports

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Unlicensed specials are medicines made on a named patient basis or imported into the UK.

What is an ‘unlicensed special’?

The Drug Tariff provides this definition of a special:

“Specials are unlicensed medicinal products manufactured in the UK for human use which have been specially prepared to meet a prescription ordered for individual patients without the need for the manufacturer to hold a marketing authorisation for the medicinal product concerned.”

If a medicine does not meet the above description, then please see the arrangements for regular medicines which are covered on this page.

Part VIIIB of the Drug Tariff (the ‘Specials Tariff’) is a tariff of high volume and high cost unlicensed specials and imports, with set reimbursement prices. The prices are set by analysis of a selection of unlicensed specials manufacturer’s prices, with a margin included for pharmacy purchase profit. The medicines list encompasses various formulations and preparations such as sugar free, preservative free, various flavours etc.


Click on a heading below to reveal more information.

Endorsements

a)   Unlicensed specials and imports listed in the Drug Tariff

The contractor is eligible to receive a fixed fee for each unlicensed special or import dispensed, to cover the costs of postage, handling and delivery etc. which may be incurred when obtaining the product from the specials manufacturer or supplier. The fixed fee is £20 per item, and can be claimed by using the endorsement ‘SP‘ on the prescription form.

Where the pharmacy chooses to supply an order for an unlicensed special item in Part VIIIB under the section 10 exemption (extemporaneous preparation and dispensing – either by the contractor or by a 3rd party), the pharmacy will receive a fixed fee of £20 to recognise the cost of extemporaneously dispensing the product or obtaining it from the 3rd party. To claim this fee the pharmacy should use the endorsement ‘ED‘ on the prescription.

As Part VIIIB prices have been calculated to include margin, Discount Not Given (DNG) claims are not allowed on these items.

Due to these separate arrangements for additional costs involved in sourcing an unlicensed special, Out of Pocket Expenses cannot be claimed against these items. Also, Broken Bulk claims are not allowed for items in Part VIIIB.

b)   Unlicensed specials and imports NOT listed in the Drug Tariff

For an unlicensed medicine which is not listed in Part VIIIB of the Drug Tariff and has been sourced under a manufacturer’s specials/importer’s licence issued by the MHRA, endorse:

  • Amount dispensed over pack size used;
  • Invoice price per pack size from which the order was supplied less any discount or rebate;
  • Manufacturers’/importers’ MHRA license number;
  • Batch number of the product supplied;
  • SP

As contractors endorse the price after any discount is applied, and reimbursement is based on this price there is no need for the pharmacy to endorse ‘DNG’ on the prescription if no discount was obtained. Also, Broken Bulk cannot be claimed on these items.

For an unlicensed medicine which is not listed in Part VIIIB of the Drug Tariff and has been manufactured under the Section 10 exemption from the Medicines Act 1968 (either by the contractor or a third party), endorse the names, quantities and cost of the ingredients used in preparing the product plus “ED” for costs incurred in dispensing a product prepared under the Section 10 exemption. Broken Bulk can be claimed on the ingredients used to make the product.

Due to these separate arrangements for additional costs involved in sourcing an unlicensed special, Out of Pocket Expenses cannot be claimed against these items.

Pricing

a)   Unlicensed specials and imports listed in the Drug Tariff

Where an unlicensed special or import in Part VIIIB is prescribed, the contractor will be reimbursed the set Drug Tariff price for dispensing the product, no matter how the product is sourced.

Where a quantity is below or equal to the Part VIIIB listed minimum volume, reimbursement will be the price for the minimum volume. If the quantity prescribed is more than this minimum volume, reimbursement will be paid on that price plus the 1ml or 1g list price for every additional 1ml or 1g prescribed. For example, a prescription for 200ml of an unlicensed special with a Part VIIIB listed pack size of 100ml, the price will be calculated as 1 x 100ml + 100 x 1ml.

Contractors should be aware that products which are classified as unlicensed specials are not eligible to have brand names and therefore are always paid on the price of the generic version where this is listed in Part VIIIB of the Drug Tariff. There are some examples of Part VIIIB items being prescribed using “common” names which have been reported to the PSNC Dispensing and Supply Team: Anoheal (Diltiazem hydrochloride 2% cream) and Epistatus (Midazolam 10mg/ml oral solution) being the most commonly asked about.

Where problems occur in obtaining Part VIIIB products, e.g. due to shortages or other supply issues, the NCSO concession may be extended to the affected products to ensure pharmacies are appropriately reimbursed where a product cannot be obtained at or below the Part VIIIB price.

b)   Unlicensed specials and imports NOT listed in the Drug Tariff

For unlicensed specials or imports where the item is not listed in Part VIIIB in the Drug Tariff, and where the product is obtained from a manufacturer under an MHRA specials licence, the pharmacy is required to endorse the invoice price of the product to allow correct reimbursement to be made to the pharmacy.

Where the pharmacy chooses to supply an order for an unlicensed special item not listed in Part VIIIB under the section 10 exemption (extemporaneous preparation and dispensing – either by the contractor or by a 3rd party), the pharmacy will be reimbursed for the cost of the ingredients in the product.

Sorting and submission

Prescriptions forms for unlicensed specials and imports should be separated from the rest of the bundle and placed in the red separator for submission.

Recording requirements

When supply an unlicensed special or import to a patient, in all instances the pharmacy is required by the MHRA to keep a record of the following for 5 years:

  • The source of the product
  • The person to whom and the date of which the product was sold or supplied
  • The prescriber’s details
  • The quantity of each sale or supply
  • The batch number of the product

These records must be available for inspection by the Licensing Authority.

In addition to the above, for unlicensed specials or imports not listed in Part VIIIB, the pharmacy must stamp, date, initial and endorse the Certificate of Analysis (CoA)/ Certificate of Conformity (CoC) with the invoice price and prescriber’s details. At the end of the month, the pharmacy must then send a copy of the CoA/CoC to the local NHS England team of the prescriber along with the prescriber’s details.

The Drug Tariff states that for imported unlicensed products not listed in Part VIIIB, where a CoA/CoC is not available, the contractor must stamp, date, initial and endorse the invoice with the invoice price less discount (where not clearly detailed by the supplier) and the prescriber’s details.

At the end of each month, the contractor shall send a copy of the appropriately endorsed COA/COC/invoice to the local NHS England team of the prescriber, allowing the local NHS England team to match expenditure to the special supplied.

Schedule of Payments

The “SP” and “ED” fees paid for the dispensing of unlicensed medicines will be displayed in the Prescription Fees section on page 1 of the Schedule of Payments. The total value of these fees paid to the contractor for the month in question will be displayed under “Additional fees – 2A unlicensed medicines”.


FAQs

Q. Can a CCG or a GP insist on where I get a medicinal product from?

No. Dispensing drugs and appliances is an essential service and pharmacists are responsible for the quality of medicines so it is their decision as to where these medicinal products are sourced.

Q. I normally source my specials through a wholesaler – how will I be paid for (and how should I endorse) my specials?

Wholesalers typically categorise products as being either a “standard line” or “special obtain” item. Items classified as “special obtains” are those which the wholesaler may not have readily available in stock and has to “obtain specially” on a bespoke ad-hoc basis. Items which are obtained in this way are not automatically considered as a ‘special unlicensed medicine’, e.g. food products, stoma or incontinence appliances, or vitamin supplement products.

To identify an unlicensed special, pharmacy staff should look for the wholesaler’s MHRA specials license number on the product packaging and invoice. For unlicensed imports, the invoice will state the wholesaler’s MHRA importers license number.

Where the unlicensed special is listed in Part VIIIB, the contractor will be paid this price regardless of how the product was sourced.

However, for those unlicensed specials and imports not listed in Part VIIIB, the contractor will be paid according to how the product was manufactured. Where the product is manufactured under an MHRA specials licence, pharmacy contractors need to endorse:

  • Amount dispensed over pack size used;
  • Invoice price per pack size from which the order was supplied less any discount or rebate;
  • Manufacturers’/importers’ MHRA licence number;
  • Batch number of the product supplied;
  • SP

Where the product is manufactured under the section 10 exemption of the Medicines Act 1968 (when a product can be made on a pharmacy premises without the need for a licence), pharmacy contractors need to endorse the names, quantities and cost of the ingredients used in preparing the product.

Along with payment for the product, the contractor will also be paid the appropriate additional payment depending on whether the product was manufactured by a MHRA licensed specials manufacturer under their licence (they must endorse SP) or manufactured under the section 10 exemption by the contractor or by a 3rd party (they must endorse ED).

Q. I have received a prescription for an unlicensed special medicine listed in Part VIIIB of the Drug Tariff, which specifies the name of a manufacturer where the prescriber wishes the medicine to be obtained from. Will I be reimbursed for obtaining the specific manufacturer’s product, or will I only be reimbursed the Drug Tariff Part VIIIB price?

Where there is an indication that the Part VIIIB item has been supplied, you will be reimbursed the Part VIIIB price. If however there is an endorsement of the specific manufacturer requested and other information such as price is also clearly endorsed (see our Dispensing Factsheet – Unlicensed Specials and Imports in the Resources section below) then you will be paid as endorsed.

Q. What should I do with COCs/ COAs for prescriptions from other parts of the UK?

For prescriptions for unlicensed specials and imports not in Part VIIIB originating from Wales, Scotland or Northern Ireland, the COCs and COAs should be retained for audit purposes, but there is no requirement for them to be sent to their health bodies.

Q. How should I endorse a prescription for Midazolam 10mg/1ml oral solution?

Midazolam endorsementThe Department of Health has agreed that, where the contractor has provided the prescribed quantity of Midazolam 10mg/ml oral solution in containers with an integral means of administration, these prescriptions will be reimbursed as multiples of the 5ml basic price listed in Part VIIIB of the Drug Tariff.

To ensure accurate payment, contractors must clearly endorse where they have supplied containers with an integral means of administration e.g. the quantity dispensed over pack size (20ml/5ml) or as 4x5ml.

Where the prescription is not endorsed to indicate that the contractor has supplied a container with an integral means of administration, payment will be based on the existing arrangements laid out in Part VIIIB – the minimum volume (5ml) plus the price/ml for any volume dispensed thereafter. Please see illustration opposite.

Q. I have a prescription for Melatonin 1mg tablets, is that an imported product?

Melatonin 1mg tablets are recognised as being an imported product from the United States. However, contractors should be aware that in 2008 the MHRA imposed restrictions on the import of unlicensed Melatonin products following the introduction of a licensed product Circadin 2mg modified-release tablets entering the market. Therefore, the pharmacy may wish to contact the prescriber to check whether he wishes to amend the prescription for the licensed version instead before dispensing.


Related resources

REF: Drug Tariff Part VIIIB

Dispensing Factsheet: Prescription Endorsement

Dispensing Factsheet – Unlicensed specials and imports

RPS Guidance on specials

MHRA Guidance Note 14 – The supply of unlicensed medicinal products

GPhC guidance on preparing unlicensed medicines

Royal College of Ophthalmologists specials guidance

British Association of Dermatology specials guidance

Medicinal Products

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