NHS Greater Glasgow & Clyde Area Drug and Therapeutics Committee
Greater Glasgow and Clyde Medicines
Medicines Update Primary Care

Medicines Update Primary Care Supplement- No.1 (March 2015)

A “Specials” Special!


A pharmaceutical ‘special’ is defined as a medicine manufactured to meet the particular needs of an individual patient.  These ‘specials’ are unlicensed and, unlike licensed medicines, are not assessed for safety or efficacy by the regulatory body.  Therefore, the prescriber will have to accept greater responsibility for the safety and effectiveness of the product.  When dispensing specials, pharmacists also have professional responsibilities and can be liable if their actions or omissions contribute to the harm of patients. 

NHS Circular PCA(P)(2013) 4 recommends that specials and imported unlicensed medicines should only be used where there is no suitable licensed alternative.  This Circular also requires community pharmacy contractors to seek Health Board authorisation before ordering and dispensing specials and imported unlicensed medicines for products not listed in Part 7S of the Scottish Drug Tariff.

 
When should a “special” be used?  


A prescriber may decide that a licensed product or formulation is no longer suitable for a patient and wish to use a “special” instead. There are four steps to consider before a prescription is issued:
1. Is a licensed alternative available? E.g. Could the licensed formulation of gabapentin of 50mg/ml be prescribed in place of gabapentin XX/5ml which is a special
2. Is there an alternative drug in the formulary that could be used? E.g. prescribe licensed atenolol solution instead of “special” bisoprolol solution.
3. Is there a licensed product that could be used “off-license”? E.g. use ciprofloxacin eye drops off-label in the ear instead of significantly higher cost “special” ciprofloxacin ear drops.
4. Could the tablets be crushed or capsules opened instead of using a “special”?
Consideration should also be given to other aspects of the patient’s medication. For example, does the patient take other solid dose medication instead of switching to all oral solutions? Or consideration of other pharmaceutical aspects e.g. Fluoxetine 10mg tablets are unlicensed and expensive. Fluoxetine has a long half-life, so if a patient is requiring fluoxetine 10mg a similar efficacy can be obtained with alternate day dosing of fluoxetine 20mg capsules, halving licensed dispersible 20mg tablets or using the licensed 20mg/5ml liquid preparation.
GGC Process
Costs of “specials” can be variable and extremely high. Although a prescriber can choose to prescribe a “special”, community pharmacists may require Health Board authorisation before dispensing these prescriptions.
Upon receipt of a “special” prescription, community pharmacists are advised to contact the prescriber to make them aware the item is a “special” and discuss the use of any suitable licensed alternatives.
If the prescriber confirms a “special” is necessary, pharmacists may then have to seek Health Board authorisation before ordering the product. This is to ensure all licensed alternatives have been considered and that products are sourced economically.
The second page of this bulletin shows how “specials” can be identified when prescribing on both EMIS and VISION systems.

Selecting a “special” on EMIS:

 EMIS - identifying specials


Selecting a “special” on VISION:

 InPS - identifying specials