The ageing population may lead to a greater needÂ for tablet products in dispersible forms
What does updated guidance on prescribing specials mean for independents?
Total spend on primary care specials in 2014 was Â£89.5m, according to the Association of Pharmaceutical Specials Manufacturers. This is less than one per cent of the total spend on all drugs and medicine in England and Wales. Yet for many pharmacy customers, these specials are a lifeline.
â€œBespoke medicines fill the gap when patientsâ€™ therapeutic needs canâ€™t be met by a medicine licensed in the UK, and this scenario could become more prevalent,â€ says Catherine Brown, commercial director of the Specials Division at Quantum Pharma. â€œThe ageing population may
lead to a greater need for tablet products in dispersible forms, due to difficulties with swallowing.
"At the other end of the spectrum, ONS statistics show that the number of births remains relatively high compared to figures for the last three decades and with this comes the increased need for medications in reduced strengths or alternative flavours for children. Allergy UK also reports on the increase in food allergies throughout the world, especially in children, which will inevitably impact on medication requirements.â€
Many patients who are prescribed specials need bespoke medicines that can be taken safely, quickly, and as required. Building strong relationships between pharmacists, prescribers and manufacturers is key to ensuring patient needs are met, as well as with the patients themselves.
New professional guidance from the Royal Pharmaceutical Society on prescribing specials â€“ updated in April â€“ is based around five principles (see panel, later)Â and uses case studies to illustrate specific points. It reflects the fact that decisions around the prescribing of specials rely heavily on professional judgement andÂ the individual patient. Prescribers shouldÂ be aware of whether or not the patient is taking the medicine themselves (or having it Â administered) and any practical issues that the patient may face with medicines use.
According to RPS guidance, patientsÂ (or carers) should know when they have been prescribed a special and are given appropriate information about whatÂ this means for their treatment. â€œWhen starting or taking over the supply of a special, pharmacists should ideally obtain information from prescribers or pharmacy teams who have previously supplied the special, as well as patients or carers,â€Â says Sandra Gidley, chair of the English Pharmacy Board.
â€œThis will include details of the formulation and patient factors such as appropriate packaging, or the needÂ for measuring devices for small doses. Prescribers should talk to the patient toÂ establish their needs and preferences to ensure that the practicalities of the treatment are understood.â€
Since patient information leaflets areÂ not routinely available for specials, and those for imported medicines may not be relevant to the patient or in a language they understand, itâ€™s essential that patients are kept fully informed.
â€œThe Medicines for Children website provides information leaflets about the use of medicines in children, some of which may be specials,â€ says Ms Gidley. â€œIt also has a leaflet about unlicensed medicines. (www.medicinesforchildren.org.uk). If a special is imported, consideration should
be given to obtaining a translated patient information leaflet and/or summaryÂ of product characteristics. If written information isnâ€™t available, verbal advice should be provided.â€
A specials survey conducted by the APSM in 2015 showed that 47.5 per cent of pharmacists are turning to RPS guidelines and 47 per cent to a GP for advice about a specials prescription. Although there is still concern that specials may sometimes be prescribed unnecessarily, this is reducing,Â and pharmacists are questioning the need or formulation with the GP.
Patient education tips from Sandra Gidley
Pharmacists may need to discuss with customers the following issues:
- Likely timescales for the supply and the need to request a repeat prescriptionÂ in good timeÂ
- How and when to order repeat prescriptions from their GPÂ
- The shelf life/in-use shelf life of the special and whether this is on the label â€“Â this may mean highlighting the need to collect the medicine promptly fromÂ the pharmacyÂ
- Quantities they need to orderÂ
- Why specials are different to licensed products
- Changes to the supplier or formulation that may alter the way the special isÂ taken or used (eg, a change in concentration).
â€œAlthough most pharmacists are confident in the support offered by manufacturers, many prescribing doctors are unaware of the role of the specials manufacturers in helping to ensure the appropriate formulation to meet patient clinical need,â€ says Sharon Griffiths, APSM chair. â€œOur members deal withÂ up to 500 different formulation requests a day and we are uniquely qualified to advise the prescribers and dispensers on many aspects of specials â€“ sometimes that means changing a formulation or even recommending that a special is not appropriate â€“ our primary concern is the patientâ€™s best interest.â€
As an overall trend, the NHS is spending less on specials and special obtains. According to James Piper, director at Avanza Pharma, there are concerns that a focusÂ to reduce the cost of specials may have unintended consequences. â€œThere are reports about patients sometimes being refused a special on the grounds of cost rather than necessity,â€ he says.
â€œThis is a matter of concern, and GP research shows that doctors are certainly less confident and comfortable about specials than pharmacists. GPs are in the frontline and facing difficult decisions about balancing cost and quality.â€
Specials can be obtained from a range of sources by pharmacists and their teams, which means they are not all manufactured in the same way. Once patient needs have been assessed, pharmacists need to work closely with manufacturers to ensure they can be met.
â€œPharmacists and their teams should agree with the supplier what they require to meet the prescription. This includes strength, formulation and, where relevant, requirements for excipients, eg, sugar-free or alcohol-free formulations, and flavourings,â€ says Ms Gidley. â€œThis is based on the pharmacistâ€™s understanding ofÂ the clinical needs of the patient. Where necessary, the agreed formulation is confirmed to the manufacturer in writing.â€
As community pharmacists get busier, speed of response is becoming increasingly important when fulfilling specials prescriptions. Patients shouldnâ€™t have to wait for a product because itâ€™s unlicensed or isnâ€™t available on the shelf. The APSM states that all of its members sign up to a commitment of timely delivery to patients, which means next-day delivery as standard. Members report that 95 to 99 per cent of orders are delivered within 24 hours.
Ms Brown says if specials suppliers want to grow and remain relevant, itâ€™s important they remain firmly focused on delivering support that drives efficiencies. â€œWe recognise that being a pharmacist is notÂ a nine-to-five job,â€ she says. â€œWe know that if a patient has to wait too long for a prescription, then next time they might go elsewhere and that means lost business. Saving time, cost and meeting patient needs quickly are therefore at the core of a successful pharmacy business.â€
Quantum Pharma has evolved its service with this in mind. Its customers can order specials up until 9pm on weekdays, and it is ready to manufacture and deliver a range of products within 15 hours of an order being placed. â€œAs time is of the essence, we offer easy access to expert formulation advice to help customers make quick decisions that are right for the patient and weâ€™ll deliver many lines by noon the next day to ensure patients get their vital medication swiftly.â€
What pharmacists need
Pharmacists need a manufacturer who can quickly advise them if a prescription can be fulfilled, and give advice to find the best patient solution. â€œOur relationship with retail pharmacists works because we actÂ as a sounding board for them,â€ says Karen Cole, group sales and marketing manager at Nova Laboratories. â€œOur customers know that weâ€™re reliable and that they can trust our knowledge and experience. As an approved supplier, we are always working on new products and formulations and our experienced in-house pharmacists can offer objective advice.
â€œWhen we get a call from a pharmacist the first thing we can offer them is competitive pricing, both on and off tariff. We also get calls asking about products weâ€™ve formulated for the NHS that they may not have seen before. Our dedicated support pharmacist and customer service team resolves many formulation issuesÂ and technical problems for pharmacies.Â At present, weâ€™re seeing more and more requests for conversion into batch products from our customers â€“ that is what they want and they know we will always act on feedback received and deliver for them were possible.â€
The five principles of prescribing specials
Principle 1 Establish the optimal treatment for the patient
All treatment options are evaluated. Specials should only be prescribed when the patient has a special clinical need that cannot be met by a licensed medicine of established safety, efficacy, and quality; this does not include reasons of cost, convenience or operational need.
Principle 2 Understand the patientâ€™s experience and make a shared decision Prescribers discuss the patientâ€™s needs, values and preferences to ensure that the implications and practicalities of treatment options are understood. When a special is prescribed this is a shared decision and patients are supported to adhere to their medicines.
Principle 3 Identify medicines and preparations
The risks and benefits of using a special will differ for different patient groups, different medicines and in individual clinical circumstances. Prescribers need to take into account the safety, efficacy, quality and cost of the different specials available to patients.
Principle 4 Monitor and review
The appropriateness of continued prescribing of a special is reviewed to ensure that it remains the best option and ongoing supply is justified by the patientâ€™s continued special clinical need.
Principle 5 Ensure effective prescribing governance
Prescribers understand the rationale for using a special and the practical implications of prescribing before initiating, transferring, or taking over responsibility for prescribing.
From Prescribing specials: Guidance for the prescribers of specials. Royal Pharmaceutical Society. April 2016.