A best practice guide for sourcing and dispensing unlicensed medicines
Following a change in the law this summer allowing price lists for unlicensed medicines to be published and shared, a shakeup in the procurement of specials has been triggered.
A BBC investigation, which has since revealed that the cost of specials to the
NHS has risen from £57 million to £160.5m in England in four years, has made the case for reform urgent and the need for transparency essential.
PSNC is in discussion with the Department of Health about introducing a tariff for some standardised specials. But that will take months – at the earliest.
Alan Krol, chairman of the Association of Commercial Specials Manufacturers (ACSM), says they are also working with the DH “about systems for controlling the cost of specials which don’t compromise the supply to vulnerable patients”.
He says the change in regulation to allow publication of price lists has been “significant” and has been welcomed by the association.
He says: “Publication of price lists will promote a wider understanding of the costs of unlicensed medicines and lead to greater transparency and confidence within the specials sector.”
And, he adds, they are committed to “working with health professionals to ensure that patient need continues to be met, for example, the recently published RPS guidance on sourcing specials”.
Q: What should I do when I receive a prescription for a special?
Follow the RPS decision guideline for supplying a special (see further advice on page 30). The ACSM advises choosing the preferred option that carries the lowest risk.
The preferred choice would be to use an already existing UK licensed medicine ‘off label’. If this is not appropriate, consider whether the special might be available in a licensed formulation in another country – then it could be imported.
Otherwise, turn to a UK specials manufacturer with a licence to formulate specials.
This is a preferred option over extemporaneous preparations as it carries a lower net risk.
For specials that have been produced in a batch, ensure the manufacturer has provided a certificate of analysis. However, a different type of certificate (Certificate of Conformity) should be provided for specials that are individually made-to-order.
Q: Should I get in touch with the prescriber?
Definitely contact the prescriber if any questions arise regarding filling in the prescription. Legally it is the prescriber who takes responsibility for any unwanted effects caused by any special, but the pharmacist can take some responsibility alongside the prescriber. The pharmacist should ensure therefore that all reasonable steps are taken to ensure certain criteria are met. This is laid out in the MHRA’s Guidance note 14 of The supply of unlicensed relevant medicinal products for individual patients.
Q: Who can/should I contact to source the special?
It may be advisable for the pharmacist to contact the specials manufacturer directly rather than go through a wholesaler, but it is accepted that this isn’t always possible, says the ACSM. Some pharmacists prefer to order from their wholesaler, but there are benefits to ordering direct from the manufacturer, for example, they will be able to answer any questions about formulation etc. And some specialists, such as Moorfields, which offers more than 120 different ophthalmic specials, should be able to answer any complex questions.
Asa Baudin, Moorfields marketing manager, says: “We now have a dedicated team who visit clinicians, theatre nurses and pharmacists up and down the country. We talk to them about their patient needs and also educate them about specials manufacture, such as the quality process involved.
“At the same time we can get feedback and identify areas of real clinical need where we can extend our specials’ portfolio. Equally, we can avoid requests for unnecessary specials where a suitable alternative might already be available. It means we can focus on innovating where there is genuine need.”
Q: How do I choose who to order from?
Again, follow the RPS decision guideline for supplying a special. But the ACSM adds: “For consistency, it’s good to use the same manufacturer or supplier for repeat prescriptions.”
Q: What details should be discussed when ordering?
Most manufacturers have qualified support desks and can give advice if required.
Q: How much do specials cost?
As many specials are bespoke, it is difficult to standardise costs (something the BBC investigation failed to explain). This is why it could be difficult to put a cap on the cost of specials, says Victoria Buyer, commercial director at Quantum Pharmaceutical. But she also agrees a transparent and fair costing system is needed.
Q: How will I be reimbursed?
As explained earlier, the PSNC is currently in discussion with the Department of Health on the reimbursement arrangements for specials and changes are expected “in the coming months”.
A PSNC spokesman adds: “The principal aim of this work is to reduce the overall amount specials cost the NHS, while ensuring that pharmacists can continue to obtain specialist medicines patients need in a timely and efficient way.”
Q: What risks are associated with sourcing, ordering and dispensing specials, and am I responsible?
For unlicensed medicine, any unwanted effects caused by the medicine are mostly the responsibility of the prescriber and, in small part, the pharmacist. This is the case unless the unlicensed medicine can be proven to be defective, and then the manufacturer would be responsible.
Quantum’s Victoria Buyer, says: “We do our utmost to make specials as safe as possible and have a dozen separate quality checks to verify the quality and accuracy of formulations. We’ve just formed a quality-control department to make sure quality and safety aren’t compromised in the need of speed.
“The responsibility for the safety of specials is a joint one. It is up to the prescriber to check the ratio of the actives is safe and effective for their patient, and for the manufacturer to police that as far as possible by asking the right questions at the order stage.”
Q: What record-keeping requirements are associated with specials?
As part of the MHRA’s Guidance note 14, reasonable steps should be taken by pharmacists in record-keeping, records of purchase, supply, product specification, batch number, expiry dates, quantity supplied and the details of the patient should be kept for a period of at least five years. Many manufacturers give a certificate of analysis for batch-produced specials or a certificate of conformity for one-off specials.
Q: What are the trends in the specials market?
Specials account for approximately 1 per cent of the total amount of prescriptions in the UK and are made up of over 75,000 different formulations.
In recent years, there has been a decline in extemporaneous preparation by pharmacists and an increase in ordering from specials’ manufacturers or suppliers – this is largely for reasons of quality, as pharmacy guidance is to use a source representing the lowest risk possible.
There has also been some increase in specials prescribing as a result of the ageing population – who represent the majority of demand for unlicensed medicines. According to the ACSM, this is a trend which will continue in line with the changing UK demographic.
In addition, there is a growth in niche areas where patient needs are being met through new unit dosage formats, preservative-free formulations and special treatment areas.
Asa Baudin at Moorfields points out that eye conditions are increasingly prevalent in old age, and they have seen some increase in specials prescribing around these conditions.
He says continuing focus on the patient will lead to a more specialist portfolio of options to meet clinical need.
“We want to build our business on trust and confidence. By supplying a consistently high-quality product, we will grow our business through recommendation and repeat orders.”
Neal Patel, head of corporate communications at the RPS, says: “Pharmacists always make the care of patients their first concern and have to be satisfied that the products they supply to patients are of the highest quality.
“Meeting the patient’s clinical need means that sometimes it is necessary to supply specials when there are not available ‘off the shelf’ medicines. The Society has taken action on this topic already by issuing professional guidance to pharmacists and sharing this throughout pharmacy.
“We believe strong co-operation between GPs, pharmacists and PCTs is needed to ensure that patients get the medicines they need at the best possible value to the NHS. We understand that negotiation is taking place nationally between the DH and pharmacy to improve the situation.”
Tips for your CPD entry on specials
Reflect: What is my process for specials?
Plan: Read this article and the RPSGB’s practice guidance (see link below).
Act: Implement/update my process.
Evaluate: Can I justify using specials and am I delivering patient benefit?
What the BBC investigation said
According to the BBC’s figures, a saving of nearly £72 million a year
could be made if all specials were limited to £75 an item. In one city in the West Midlands, they found that costs varied from £50 to £1,556 for the same item.
The mark-ups occurred when pharmacists bought through wholesalers, not direct from the manufacturer, the BBC reported. Some wholesalers offered large discounts to pharmacists, the BBC added.
- BCM Specials has recently relaunched its website: www.bcm-specials.co.uk
- Moorfields has a dedicated specialist helpline particularly for ophthalmic queries and has an online resource for ophthalmic professionals, including pharmacists at: www.dryeyesmedical.com
- PSNC: www.psnc.org.uk
- RPSGB good practice guidance: www.rpharms.com/support-pdfs/ppjune2010-specials.pdf