There can be many reasons to turn to a special medicine; perhaps the patient requires a different strength or formulation; perhaps the licensed medicine they need has been discontinued altogether; a different patient might be allergic to certain ingredients in the licensed product; improving compliance in a patient who may be unwilling or unable to swallow a tablet; yet more patients could require cream, solution, ointment or suppository alternatives. In all the above cases and more, the pharmacist will need to prepare or, more often than not, procure a special medicine from a specialist manufacturer.
The role of the specialist manufacturer
In the past such unlicensed medicines were put together using a simple pestle and mortar by the pharmacist or technician in the back of the store. Needless to say, technology and legislation has moved on significantly and pharmacists need to provide ever more complicated formulations. However, certain challenges remain for the pharmacist to overcome.
For a start, the Royal Pharmaceutical Society recommends, “a pharmaceutical special medicine should only be used where there is no suitable licensed alternative”. So each prescription has to be checked thoroughly to ensure that a licensed alternative is not available before deciding to create a special. The pharmacist also needs to dispense a product that meets the needs of the patient, while still adhering to the Code of Ethics. This clearly states that the pharmacist must, “be satisfied as to the integrity and quality of products to be supplied to patients”.
These complex requirements have led to the preparation of special medicines being undertaken more and more by licensed specialist manufacturers who can deliver a variety of medicines in alternative formulations, practically overnight – reassuring busy pharmacists that they can continue to provide customers with high quality bespoke prescriptions on demand. Of course, to produce special medicines in the UK a manufacturer must hold a manufacturer’s (specials) licence showing their compliance with the criteria set out by the MHRA. Yet the more reputable specials manufacturers go a lot further. They have a team of highly trained pharmacy technicians and pharmacists who run every product they supply through a series of stringent quality checks throughout the production process – during preparation, while the medicine is being mixed and after the process has been completed. This attention to detail at every stage ensures the medicine that is ultimately signed off, delivered and dispensed, is of the highest quality and accurately matches the requirements specified by the pharmacist.
Each special medicine is supplied with a Certificate of Analysis, or a Certificate of Conformity. For any batchmanufactured special, a Certificate of Analysis gives evidence that critical parameters have been confirmed by retrospective physical, chemical or microbiological assay of a sample of the final product. A Certificate of Conformity is a signed statement by the manufacturer confirming that the product complies with the purchaser’s specification.
The role of the pharmacist
Even with the watchful checks and processes in place during the production process, it remains good practice for a pharmacist to make sure that they check the quality of the special medicines they receive from the specials manufacturer. Have they checked that the manufacturer labels and packages product in accordance with the latest guidelines? Do they provide supporting governance documentation? Are they delivering the medicine to the patient in a timely fashion in the appropriate condition and at the correct temperature? And of course, the pharmacist should take all reasonable steps to confirm the strength, formulation and excipients of each special medicine they are supplied with to ensure it is pharmaceutically appropriate and suitable for the patient before being dispensed.
The pharmacist also needs to be confident that the manufacturer they use is always checking whether a licensed alternative is already available for each request, in case they should produce an ‘unnecessary special’. Furthermore, the shelf life of a special medicine product can be very different to the licensed alternative and some special medicines can have a very short expiry, sometimes as low as seven days. So the pharmacist should also check that they have evidence to support the labelled shelf life of each individual product. This means the prescriber and pharmacist both need to be aware of the potential need to arrange four prescriptions for a month’s supply of a particular special medicine.
The balance between cost and quality
The manufacture of bespoke special medicines has grown into an essential service, enabling particularly vulnerable patients to continue receiving appropriate prescriptions. Naturally, this has led to an increased focus on the cost of specials prescriptions. A recent BBC report showed that the cost of specials to the NHS rose from £57m to £160.5m in just four years and that a potential saving of nearly £72m could be made if all specials were limited to £75 per item. This report also revealed that some trusts had paid between £50 and £1,556 for the exact same medicine (captopril liquid 25mg/5mls).
The Royal Pharmaceutical Society has issued a Support Update discussing points pharmacists should consider when procuring and supplying unlicensed specials and cost as a factor. The Support Update notes that pharmacists have a responsibility for procuring and supplying specials in a professional manner.
The RPS advises that:
- A licensed product should be supplied in preference to an unlicensed product.
- If an unlicensed special is required pharmacists should consider the patient’s requirements and identify a suitable product.
- Changes in legislation mean that manufacturers of unlicensed specials can publish and share their price lists. This makes it possible for pharmacists to access pricing and availability information more easily.
- Pharmacists are encouraged to ensure that the NHS receives good value from its expenditure. It is recommended that a standard operating procedure detailing the steps involved in ordering specials be put in place. The SOP should advise staff to regularly check that a chosen supplier is offering the best all round service, taking into account quality, promptness of supply and value for money.
The future for specials
Special medicines provide an invaluable lifeline for patients who, for whatever reason, can’t take a licensed formulation. With the manufacture and supply of these crucial medicines being increasingly outsourced, the quality of the products that are dispensed should increase. What remains to be seen is how the costs of this growing service will be managed and the impact that this will have on healthcare professionals’ budgets.