The process of purchasing Specials is usually more complicated than purchasing licensed medicines, especially when they are being purchased for the first time. Our article on Understanding unlicensed medicines provides further information about the difference between licensed and unlicensed medicines.
In our articles we refer to both UK manufactured unlicensed medicines and imported unlicensed medicines as “Specials” in line with the MHRA’s Guidance Note 14.
It may be necessary to identify and evaluate a number of purchasing options in collaboration with the prescriber and potential suppliers.
The approach may differ depending on whether an entirely new product or an existing formulation is to be purchased, and whether there is a local or national contract already in place. Nevertheless, considerations will include:
- the required characteristics of the medicine as defined in a purchasing specification
- identification of a suitable manufacturer or importer
- assessment of the quality of the medicine
- checking medicines on receipt
Specifying the patient’s requirements
The first step in purchasing a Special is to define the purchasing specification. This will include all the requirements of the prescriber and the patient, for example:
- route of administration
- strength or concentration range
- flavour, smell or appearance
- number of tablets or volume of liquid for each dose
- release characteristics and bioavailability
- number of units required
- any specific labelling or information needs
It may be necessary to work with the prescriber to define which characteristics are essential and which are desirable in case a medicine with all the requirements cannot be found.
Standardised formulations should be purchased wherever practicable. These may include, but are not limited to:
- NPPG Using Standardised Strengths of Liquid Medicines in Children
- Dermatology Special Medicines
- Chemotherapy dose banding
Identifying a suitable supplier
Purchasers must ensure that Specials are sourced from reputable suppliers with the correct MHRA licences.
UK Specials manufacturers
UK manufactured Specials may only be manufactured by the holder of a Specials Manufacturing Authorisation (MS) from the MHRA. These range from large factories, to small units employing a few people, and may be in the commercial sector or the NHS. The NHS Specials manufacturing units that supply outside their own Trust are listed on ProFile (registration required, NHS only).
Sometimes, a third party with a wholesale dealer authorisation may offer a UK manufactured Special. The wholesaler should be able to provide information about the manufacturer so that the purchaser can check its authenticity.
To import medicines from other countries it is necessary to hold an appropriate MHRA licence:
- medicines from an MHRA approved country must be imported by a Wholesaler with a licence that authorises imports
- medicines from outside an MHRA approved country must be imported by a Specials manufacturer with a licence covering imports.
The MHRA’s role
Before importing a medicine, an importer must notify the MHRA of their intention and wait for a response (sometimes called a “no objection” letter). The MHRA does not approve unlicensed medicines, but may object to importation if there is no evidence of Special Clinical Need, they have concerns about the pharmaceutical quality of the medicine, or if there are clinical safety issues. There are restrictions on the quantity of any individual unlicensed medicine that may be purchased at one time, so importers hold limited stocks.
In some cases, the “no objection” letter may include conditions such as requiring safety information to be communicated to clinicians.
Assessing the suitability of suppliers
All MS holders are listed on the MHRA’s Human and veterinary medicines: register of licensed manufacturing sites. This shows the MS number, name and address of all Specials manufacturers, and indicates the range of dose forms that the manufacturer is licensed to make. This enables purchasers to check that the prospective supplier has an appropriate licence for the manufacture of the medicine to be purchased.
The MHRA also holds a list of holders of Wholesale Dealer Authorisations (Wholesale Dealer’s Licences (WDL))
Medicines made under a MS licence may be sold to suitable external organisations without the need for Wholesale Dealer’s Licence (WDL).
Lists of wholesalers and manufacturers that have recently had their licences suspended by the MHRA are also available.
The NHS does not maintain a single list of approved suppliers. Some Specials manufacturers are evaluated or audited as part of regional or national frameworks. This information is communicated as part of the contract implementation pack issued to Trusts.
In some cases, Specials manufacturers may have been audited by Regional Quality Assurance specialists. This does not constitute approval, but the report may Inform the decision-making process when a Trust decides on the suitability of a supplier.
In other cases, the purchaser or local procurement networks may have their own approved supplier list with whom they have a history of timely supply of suitable quality medicines.
Understanding quality assessments
Specials have not been evaluated for quality, safety and efficacy by the MHRA, so it is essential that the purchaser takes additional steps to gain assurance that the medicine is
- of appropriate pharmaceutical quality
- meets the purchasing specification and is suitable for the patient
- labelled and packaged in a way that minimises the risk of medication error
Quality assessments should be undertaken before a medicine is purchased for the first time and should be periodically reviewed to ensure that there have been no changes. The presence of an unlicensed medicine on the Drug Tariff or in the BNF etc. does not indicate that the quality of the medicine has been assessed.
In some cases, SPS may perform quality assessments in support of licensed medicines supply issues.
Obtaining and evaluating information
Information to enable local quality assessments should be readily available from the supplier.
Ideally, a Specials manufacturer or importer will be able to provide a finished product specification that provides all the details required to enable an assessment to be made. In practice, this is rarely the case, so additional information needs to be requested. The information needed depends on the type of Special (UK manufactured or import) and the medicinal form. Examples include where the medicinal form is:
- aseptically prepared
- solid dose
Our forthcoming article on obtaining and evaluating quality information will provide additional guidance.
If a supplier is reluctant to provide information, this should be a cause for concern and consideration should be given to purchasing elsewhere.
Recording the assessment
The information obtained and the outcome of the evaluation should be documented, and should include an overall conclusion about the suitability of the medicine for the patient or patient group. This conclusion should be reported using local governance structures.
Agreeing a finished product specification
The final product specification should be agreed between the purchaser and supplier. This can be straightforward, for example if the medicine is an import licensed in another country, or an existing product made by the manufacturer. Some cases may require considerable discussion, for example if the product has not been made before.
The purpose of a purchasing specification is to ensure all parties are clear about exactly what is required. It may take the form of a purchasing specification prepared by the purchaser and accepted by the manufacturer, or a finished product specification accepted by the purchaser. It is often useful to include photographs in the purchasing specification to facilitate receipt checks.
This step is often performed at the same time as assessing the pharmaceutical quality of the medicine, again depending on the type of unlicensed medicine and its characteristics.
All Specials should be quarantined on receipt until they can be checked by a suitably competent person for compliance with the purchasing specification. Overall responsibility for checks following receipt sits with the purchasing pharmacist, but the individual checks may be delegated. Local procedures should define who may undertake these checks, and the steps to take if any discrepancies are identified.
In most cases, a certificate of analysis or certificate of conformity should be provided with the unlicensed medicines. This should be checked for completeness and that it corresponds to the batches received. Some manufacturers make these available on their websites, rather than as a hard copy.
Certificates of analysis include the results of finished product testing. These should be available for all medicines with a shelf life longer than 89 days, and should be checked against the manufacturer’s finished product specification.
Certificates of conformity confirm only that the batch has been made according to GMP and that it has been released by an approved releasing officer. These are commonly provided for medicines with a shelf life of 89 days or less, for which finished product testing is not required by the MHRA. For further information about the MHRA’s expectations, refer to sections 3.6.16 and 3.6.18 of Guidance for ‘specials’ manufacturers
The NHS Pharmaceutical QA Committee produced the following document, which has not been reviewed since 2016. This document will not be updated, however, it still has valid content that can assist with risk management and local decision making.
- links included for standardised formulations