MHRA Guidance Note 14 - The supply of unlicensed medicinal products ("specials")

Specials Manufacturers/Suppliers Contact Numbers

Specials and Unlicensed Medicines (ULM)

What is a 'Special'?

Most drugs prescribed for patients are licensed medicinal products.  Very rarely a patient will need a medicine which is not already available on the market; it then has to be specially made.  This might be because a liquid is required to overcome swallowing difficulties, or to facilitate administration of unusual doses.  A patient may be allergic or intolerant to an ingredient in the licensed product, or it is unsuitable (e.g. alcohol is an ingredient in some liquids needed for infants).  To address these needs, specially prepared products are produced by specialist manufacturing units which have obtained a specials manufacturing license from the MHRA.  This means the facilities of the supplier have reached a minimum standard.  It does not mean the product is licensed.

A pharmaceutical ‘Special’ as defined by law is a medicine made to satisfy the needs of an individual patient.  These so-called ‘Specials’ are unlicensed and, unlike licensed medicines, are not assessed for safety or efficacy by a regulatory body.  Therefore, the prescriber may have to accept greater responsibility for the safety and effectiveness of the product.  As ‘Specials’ are made under a ‘Specials’ manufacturing license, different companies may use different formulations (the exact contents can differ every time), and may have no safety, stability or efficacy testing.

‘Specials’ differ from unlicensed products that can be prepared in a registered pharmacy through a process usually referred to as ‘extemporaneous dispensing’.  The latter are not defined in law as ‘Specials’ and are exempt from the usual requirements of the Medicines Act 1968 for quality, safety and efficacy (sometimes referred to as ‘Section 10-exemptions’).  The volume of extemporaneous dispensing undertaken in community pharmacies is now very small as this is largely sub-contracted to ‘Specials’ manufacturers.

What does it mean for the Prescriber and dispensing Pharmacist?

The responsibility that falls on healthcare professionals when prescribing an unlicensed medicine or a medicine off-label/off-license may be greater than when prescribing a licensed medicine within the terms of its license.  Prescribers should pay particular attention to the risks associated with using unlicensed medicines or using a licensed medicine off-label/off-license.  These risks may include adverse reactions, product quality, or discrepant product information or labelling (e.g. absence of information for some unlicensed medicines, information in a foreign language for unlicensed imports, and potential confusion for patients or carers when the Patient Information Leaflet is inconsistent with a medicine’s off-label use).

General Medical Council (GMC) guidance recommends that prescribers should usually prescribe licensed medicines in accordance with the terms of their license.  However, prescribers may prescribe unlicensed medicines where, on the basis of an assessment of the individual patient, they conclude, for medical reasons, that it is necessary to do so to meet the specific needs of the patient.

Prescribers are often unaware of the costs of ‘Specials’.  The development in February 2013 of the Scottish Drug Tariff Part 7S, a limited list of ‘Special’ preparations, reduced the variation in cost of those products listed. However, ‘Specials’ are still generally more expensive than licensed medicines and remain unregulated, with a wide variation in quality of different specials depending on the manufacturer.  ‘Specials’ that can be obtained from NHS Pharmacy Production Units (e.g. Pharmaceutical Services Scotland (PSS), formerly Dayside Pharmaceuticals Dundee) are often the most cost effective options.

Pharmacists, when dispensing, also have professional responsibilities and can incur liability if their actions or omissions have contributed to the harm of patients.  It may be necessary for the Community Pharmacist to discuss this and the appropriateness of the ‘Special’ prescription with the prescriber or Prescribing Support Pharmacist so that all parties are fully aware of the implications, status and cost of an unlicensed product being supplied.  It is recommended that the Community Pharmacist document this.  NHS Circular PCA(P)(2015)17 also requires Community Pharmacy Contractors to seek Health Board authorisation before ordering and dispensing ‘Specials’ and imported unlicensed medicines which are not listed in Part 7S of Drug Tariff or available from an NHS manufacturing unit in Scotland, England or Wales.

Process for Authorisations

As a result of the ongoing pandemic situation, NHS GGC suspended the need to seek authorisation for some of our more commonly used and low cost “Specials”.  Community pharmacy teams are asked to continue to follow their normal ordering/procurement processes and order stock through their normal suppliers, using the prices contained within the guide.

Authorisation is not required when:

• The product is a UK licensed medicine
• Products are:
  • Listed in Scottish Drug tariff part 7s, part 7u
  • Listed on the pre-approved price list
  • Available from the NHS manufacturing unit, Pharmaceutical Specials Service (PSS) – formerly Tayside Pharmaceuticals
• The product is not a medicine e.g. stocking, dressing
• Authorisation has been obtained within last 12 months with less than 10% price variation from original authorisation

If you are presented with a script for a ULM or import not on the list or has been previously authorised for you, then seek authorisation using the approved form and email to prescribing@ggc.scot.nhs.uk.  Please remember:

• All requests for authorisation MUST be sent from the clinical mailbox
• DO NOT use company or personal e-mail mailboxes
• Specials authorisation forms MUST NOT be sent as an image

In order to comply with GDPR regulations, download and complete the online form and save as an attachment and submit using your pharmacy clinical mailbox.  Do not send patient identifiable data from an unsecure e-mail address and/or the e-mail has included an image of the form that has been taken on a personal mobile device.

There is a monthly analysis of the Specials payments when the Board will contact the contractor with a query on the price.  This will give you 28 days for the contractor to contact Central Prescribing Team to discuss the recovery.  Each will be considered on an individual basis.

Contractors are reminded of the need to correctly and accurately endorse the prices on all ULMs not listed within Part 7S/U.  You are also entitled to claims for the negotiated £30 handling charge paid on all non SDT Part 7S/U items, including those listed in the local guide price.

Responsible Person: Elaine Paton

Last Updated: 09/04/24