Pharmacists have a responsibility to ensure that when specials are dispensed, it is done correctly. Decisions about how best to procure and supply specials rely heavily on the professional judgment of pharmacists, based on their expert understanding of medicines.
Specials are a category of unlicensed medicines that does not have marketing authorisation in the European Union, or in the UK. They are manufactured, imported or distributed to meet the special clinical needs of an individual patient.
There is a range of diverse clinical situations when specials may be judged by the prescriber and agreed by a patient or carer to be the most appropriate option on the basis of the available evidence.
For example, in children, specials may be the only option for the prescriber for some conditions – and in some circumstances they are prescribed routinely. In dermatology and ophthalmology, there is often a large number of specials in use, and formularies have been produced to improve access to, and inform the prescribing of, specials.
However, the Medicines and Healthcare products Regulatory Agency (MHRA) specifies that a special clinical need does not include reasons of cost, convenience or operational need.
Specials, like all unlicensed medicines, should only be dispensed when there is no available licensed medicine that fully meets the patient’s special clinical needs.
Guidance on specials
The new guidance from the Royal Pharmaceutical Society (RPS) on specials aims to support pharmacists and their teams to work with prescribers, patients and carers to ensure the safe and appropriate procurement and supply of specials.
Increasingly, community pharmacists now buy specials rather than preparing these medicines extemporaneously within the pharmacy. The RPS says there has also been a “steady growth in the use of homecare services to dispense and supply ready-to-administer medicines – many of which are specials – to patients at home”.
The RPS guidance comes at a time when the society says there is an “increased focus on governance” to ensure that specials are always procured and supplied safely and appropriately.
What’s new in the updated guidance is the inclusion of case studies that illustrate the challenges that pharmacists face when ensuring patients receive optimal treatment. The RPS says that these case studies are “broadly applicable to other unlicensed medicines that pharmacists may be required to supply”. The case studies illustrate the key ways that pharmacists can support prescribers when it comes to specials, such as the importance of having a full product specification available, and sharing information in a timely way.
Prescribing budget pressures
The new guidance is an update of a resource that was first published in 2011 by the National Prescribing Centre. In the past five years, there have been changes in clinical practice and in the NHS – not least the growing pressure on prescribing budgets.
In a survey of GPs conducted in June 2013, more than half (54%) said they had been asked by their clinical commissioning group (CCG) to reduce prescribing of specials.
The equivalent of 10 million specials were dispensed by pharmacists in the community in 2014. This volume is made up of a huge array of different formulations, ranging from creams and liquids to intravenous drugs and injectables.
The average cost of a special item has fallen in recent years, according to the Association of Pharmaceutical Specials Manufacturers (APSM). It has fallen faster than the decrease in the average net ingredient cost of prescriptions in England, which fell by 25% since 2003-04, according to data from the Health and Social Care Information Centre. Spending on specials accounts for just over 1% of total spend on prescriptions – equivalent to £1.74 per person, compared with £165 per person on all prescriptions.
In recent years, as part of growing pressure on NHS budgets, the cost of specials has come under scrutiny. Costs are regulated by the Drug Tariff, and in the past three years, the overall cost of specials has reduced by almost 30%, figures from the APSM show.
But there are concerns that increased pressure to further reduce cost could be compromising quality through sourcing lower cost supply, or even reluctance to prescribe a special when required.
However, when a special is indicated, attempts to cut cost in the supply chain could result in increased demands on the NHS budget, manufacturers warn. So there is a need to have robust guidance and regulation in place to provide a framework for specials to be prescribed when there is no alternative to meet patient need.
The updated RPS guidance also reflects regulatory changes made in 2014 by the MHRA, in a document on specials, called Guidance Note 14 .
The guidance reflects the “specific challenges” that the use of specials presents, according to RPS English board chair Sandra Gidley. To this end, she says that it’s important that pharmacists are aware of the “complexities and risks” associated with the supply of specials, for example when patients move between care settings. As a result, this is given more emphasis in the updated guidance, and “communication between prescribers and pharmacy colleagues is also emphasised”, she adds.
“Prescribers and pharmacists both have a responsibility to ensure that where specials are prescribed they are the most appropriate choice and patients are supported to use them effectively,” says Ms Gidley. “So we encourage pharmacists and prescribers to work together to ensure that patients are prescribed specials appropriately and are supported to adhere to their treatment.”
What should pharmacists remember about specials?
It’s important that prescribers and pharmacists consider all options available to their patients before prescribing and supplying a special. Considering all the available options with the support of a GP colleague (and in consultation with the patient) can also result in an equally effective licensed medicine being prescribed for the patient.
When transferring responsibilities for the prescribing and supply of specials, organisations must have processes in place to support full and timely communication. This might include template letters to be sent to GPs on discharge and/or direct contact with the patient’s preferred community pharmacy.
There’s a need for clear communication with patients and carers about the practical differences between licensed medicines and specials – specifically about the timescales necessary for the special to arrive in the pharmacy, and the impact this has on the ordering of repeat prescriptions.
Prescribers and pharmacists should have a full product specification available when a patient transfers from one setting to another, and share this information in a timely way.
Don’t use in isolation
However, other commenters advise caution, including the APSM. The organisation exists because it is a costly process taking a medicine to licence, and pharmaceutical manufacturers have little incentive to create certain drugs in all formulations where their potential dispensing volumes are small – even if there is a patient need. In these instances, where there is no licensed medicine to meet this patient need, a specially formulated unlicensed medicine must be prepared by a specials manufacturer.
APSM chair Sharon Griffiths says that although the RPS guidance is “an important source of reference for pharmacists when advising about and dispensing specials” and “more comprehensive” than the society’s previous guidance, it shouldn’t be used “in isolation” by pharmacists.
According to Ms Griffiths, the RPS guidance is less “explicit” than the MHRA’s document on specials, and also has several other key differences.
Firstly, she says the risk hierarchy that was included in the MHRA document is omitted from the RPS guidelines. This provided useful information on the hierarchy for the use of unlicensed medicines, and Ms Griffiths says it is “a fundamental guiding principle to protect patient safety [that] recognises risk management for specials”. The APSM “would like to see it reintroduced,” she adds.
Secondly, Ms Griffiths argues that the RPS guidance does not make enough provision for “medicines used for indications for which they are not licensed or where the dosage form is manipulated” – which she says she interprets
“to mean crushing tablets”.
She says: “The risks of crushing tablets are widely accepted within the profession and by regulators, although it is still sometimes recommended, [but] the APSM doesn’t believe that dosage manipulation should be encouraged.”
Ensuring patient safety
Catherine Brown, commercial director of the specials division at Quantum Pharma, stresses the important role that community pharmacy continues to play in the supply of specials.
A survey by the APSM last summer found that pharmacists have a positive view of the role of specials, with 80% agreeing they are essential to meet the special clinical needs of some patients.
Ms Brown says that specials manufacturers can help ensure patient safety and adherence, by offering pharmacists support.
“In the latest APSM survey, more pharmacists agreed with the statement ‘I think specialist pharmaceutical companies should make up specials’,” says Ms Brown. “Therein lies the point – we can’t expect community pharmacies to replicate the safety, speed and quality of a specialist. Where we can bridge the knowledge gap is by making sure pharmacies are confident at commissioning this service to the right provider and supporting adherence through expert engagement with the patient.”
Ms Brown suggests there is another layer of support, in the form of the specials sector itself, which she says “should be supporting pharmacy teams to source specials in a way that’s convenient to them and in line with the new 24/7 NHS”.
“Specials manufacturers can also assist pharmacists by helping them navigate the endorsing process to ensure they aren’t out of pocket, but crucially, by giving guidance they can trust when those occasional but critical special requests come their way.”
The right guidance and support can help pharmacists to use their knowledge to make sure that, even though they may not dispense specials often, they get it right for the patient, the prescriber and the pharmacy – every time.
Case study: A local GP has requested my pharmacy supplies an NHS prescription for melatonin 1mg capsules and there is no licensed medicine available
What should I do?
Leyla Hannbeck, NPA chief pharmacist
The only licensed melatonin product available is Circadin 2mg modified-release tablets, which is indicated for short-term use in adults aged 55 years and older who have insomnia. Melatonin 1mg capsules do not have a marketing authorisation in the UK, and are only available as an unlicensed medicine.
Firstly, as this is an unlicensed medicine, you should contact the prescriber to check the indication, the dose and any other relevant information. The prescriber may wish to use a suitable licensed alternative, but if they decide to prescribe an unlicensed medicine, you should advise the patient about the medicine’s unlicensed status and provide additional information to ensure the patient understands its use.
For example, you should advise the patient to report any adverse effects to their prescriber. This should be done without undermining the patient’s confidence in the medicine, or in the prescriber.
You should then place the order with a specials supplier. The Medicines and Healthcare products Regulatory Agency (MHRA) has advised manufacturers of unlicensed medicines to obtain confirmation of specials orders in writing, for example, by fax, email or, where applicable, through the manufacturers’ online ordering system. This is to ensure that transcription errors do not occur at the time of placing the order, leading to the wrong product being sent to a pharmacy or being dispensed to a patient.
The process for ordering specials from manufacturers of unlicensed medicines should be reflected in your pharmacy’s standard operating procedures.
After dispensing the medicine, you should keep accurate records of the supply – both in the patient medication record (PMR) and in the specials procurement record book. The prescription should then be endorsed correctly, according to Drug Tariff rules, and submitted for payment.