As with all unlicensed medicines, the pharmacist and prescriber share the professional accountability for supplying a ‘Special’ to a patient. However, as ‘Specials’ can be difficult to identify at the point of prescribing63 prescribers may be unaware that they are considering prescribing one. If in doubt, clinicians should discuss with pharmacists before prescribing. Pharmacists have a professional responsibility to ensure that the prescriber is aware of the unlicensed nature of any ‘Special’ dispensed61, and if requested, to make every effort to identify a UK licensed product equivalent, or near product equivalent, to the prescribed special that meets the patient’s clinical needs.
Tips to help prescribers identify ‘Specials’63
- If a medicine is not in the BNF it could be a ‘Special’*
- Dermatology products, eye drops and liquid preparations may be formulated as ‘Specials’
- Electronic prescribing systems may not identify ‘Specials’. Some systems may use the letter ‘U’ to indicate an unlicensed medicine, or misleadingly highlight the cost of ‘Specials’ as ‘zero’.
- Clinical systems can be used to highlight that a ‘Special’ is being selected and potentially suggest alternatives.
- Community pharmacists may wish to check with prescribers if they think a prescriber is unaware they are prescribing a ‘Special’. Pharmacists have responsibility to help ensure that prescribers are aware they are prescribing an unlicensed medicine.
- In hospitals, clinical pharmacists may highlight to prescribers they are prescribing a ‘Special’.
* For some preparations the BNF and BNF for Children indicate whether the preparation needs to be obtained through a ‘special-order’ manufacturer, or a specialist importing company. Where an unlicensed drug is included in the BNF, this is indicated in square brackets after the entry. When the BNF suggests a use (or route) that is outside the licensed indication of a product (‘off-label’ use), this too is indicated. In the BNF for Children individual drug entries give an indication of the licensed status of the drug.
‘Specials’ – including extemporaneously prepared medicines and altered formulations – are commonly given to some of the most vulnerable patients in hospitals and communities (eg. neonates, children, older patients, stroke patients, patients with feeding tubes in situ). These vulnerable patients are often not capable of alerting carers or staff to any adverse drug events they may be experiencing. To support prescribers, the National Prescribing Centre (now NICE Medicines and Prescribing Centre) has documented ‘five guiding principles for prescribers’ when prescribing ‘Specials’63:
Prescribing: a quick checklist for prescribers
1. Establish a clinical need
Prescribers should be vigilant when they are prescribing a Special, or asking another professional to administer one. In general Specials should only be prescribed when the patient has an individual clinical need which cannot be met by a licensed medicine of established efficacy, quality and stability.
Does the patient need a medicine? Is it essential for this patient? Is there a licensed preparation which could meet the patient’s needs, for example soluble tablets, liquid formulations, or patches? What are all the unlicensed alternatives? Is local guidance available?
2. Identify medicines and preparations
The risks and benefits of using a Special will differ for different patient groups, different medicines and in different individual clinical circumstances. Prescribers need to take into account the safety, effectiveness, quality and cost effectiveness of all the options available to patients.
What is the rationale for using an unlicensed medicine? Is there evidence or accepted practice to support usage? Is the dose critical? Is the patient a child? Does the medicine have a narrow therapeutic window? Is there a requirement to specify the exact formulation? What is the best value-for-money? Is there any local guidance?
3. Make a shared decision with the patient or carer
Prescribers should discuss treatment options with patients and carers and ensure that they are aware of the implications and practicalities of each option.
What are the practical implications of prescribing? What is the shelf-life? How often will prescriptions be needed? How long does it take to obtain? Will the patient be taking the medicine themselves or will it be administered? Are there any implications for the choice of product?
4. Ensure prescribing governance
Prescribers should understand the rationale for using a Special and the practical implications of prescribing before initiating, transferring, or taking over responsibility for prescribing.
If initiating prescribing, how long is the patient expected to need this medicine? If asking someone to continue prescribing, are communications with the new prescriber optimised? If continuing the prescribing of a Special, do prescribers know the formulation and source of the initial supply? Is there a need to ensure consistency of dose by specifying the formulation?
5. Ensure ongoing monitoring and review
Prescribers should have systems in place to ensure the need for the Special is regularly reviewed, both in terms of the continued need for a Special product and in the context of the need for a medicine overall.
How often will the patient be reviewed? Who will do the review?
Broadly, prescribers and pharmacists must be able to demonstrate that they have acted with due diligence in regards to patient safety, and that they have taken all reasonable steps to ensure62:
- Procurement from an appropriate source
- That the product is of appropriate quality
- That the product meets the particular clinical needs of the patient: this may require dialogue with the manufacturer, and if relevant the hospital pharmacy, about formulation, strength, etc.
- That all relevant records are kept.
Find alternatives to
solid dose medications
- Prescribing ‘Specials’ – Five guiding principles for prescribers. NPC.
- Dealing with ‘Specials’. RPSGB.
- Information and guidance on the prescribing and use of unlicensed pharmaceutical specials. East of England NHS Collaborative Procurement Hub.
- Association of Pharmaceutical Specials Manufacturers
- Manufacturer’s and wholesale dealer’s licences. MHRA.
- Introduction of a 'Specials' tariff. NHS Prescription Services.
- Professional Guidance for the Procurement and Supply of Specials” Royal Pharmaceutical Society