The supply of specials involves ongoing collaboration and communication to ensure the dispensing process runs as smoothly as possible.
When it comes to specials Thorrun Govind, community pharmacist at Sykes Chemist in Bolton says pharmacy staff will need to take a different approach from when they deal with normal prescriptions or over-the-counter sales. “Some specials are for patients who are really unwell, so we need to make sure they get their medicines on time,” she says. “We need to make sure we have high quality product from a regulated provider, so need to be able to trust the company we use.”
According to Sharon Griffiths, chair of the Association of Pharmaceutical Specials Manufacturers (APSM), the Royal Pharmaceutical’s guidance in 2015 underlined the importance of the prescriber and pharmacist working together to agree medication and formulation. But, she says, although the Specials manufacturers can also play an important role, many prescribing doctors and even community pharmacists aren’t aware of the clinical support role they can provide.
“As a requirement of membership, APSM members have expert customer service teams and in-house pharmacists whose role it is to provide advice and guidance about any aspect of a Specials prescription,” she says. “It is often the case that the Specials manufacturer points out that there is a licensed formulation available. Similarly, our expertise in sourcing and combining APIs and excipients means we may recommend an adjustment to the formulation to provide a less expensive prescription, or a formulation that offers a longer shelf-life, or better patient experience. In essence, when we know what a prescriber wants to achieve, we can help develop the most effective way of delivering it.”
Nova Laboratories says independent pharmacies need to work closely with an approved specials manufacturer to get the most from the relationship. “We find that the main challenge for independent pharmacists is having the in-house knowledge and resource to be able to tackle prescriptions quickly and efficiently,” says Karen Cole, group sales and marketing manager at Nova Laboratories. “Many need a specials manufacturer that effectively acts as an outsourced consultancy on technical issues, as well as a provider of unlicensed medicines to fulfill prescriptions. Specials prescriptions can also often prove an administrative burden on pharmacies, especially if prescriptions are less common or familiar to the pharmacists. It’s advisable to keep a record of suppliers that are able to fulfill certain prescriptions to avoid having to contact multiple manufacturers each time. On top of this, pharmacists need to know their customers will be satisfied with the quality and speed of delivery of the product so it’s important to work with a manufacturer you can trust.”
Catherine Brown, commercial director at Quantum Pharmaceutical, recommends that pharmacists ask certain questions before making a decision on choice of supplier. “It is important for those determining which specials supplier to use that quality of service, quality of delivery and quality of product are key factors in the decision-making process,” she says. “This will ensure the patient and the pharmacy can be assured of a quality process from end to end and full confidence that the product received is compliant, delivered promptly and to the highest quality. Not only that, but full support available at all times when the pharmacy may need it during opening hours, such as technical product advice, delivery information or paperwork for ensuring accurate reimbursement.”
According to Jonathan Hodgson, director of Rokshaw Laboratories, all specials companies were informed in January 2017, after guidance from the MHRA and the GPhC, that all orders should now be confirmed in writing. These regulations are compulsory and considered complementary to the GPhC guidance that was issued on 14th April 2016. The regulations have been imposed to reduce the risk of the wrong product being supplied to the pharmacy and then potentially to the patient.
“This guidance has come from the need of ensuring the correct product is manufactured to a patients’ unique requirements,” he says. “When it comes to a written confirmation, a specials company can advise a pharmacy to confirm their order via email, fax or an online ordering system.”
Most specials are unlicensed products, which means they don’t undergo the same finished product testing as licensed medicines. “When you manufacture a one-off for one patient it can’t be sent away for testing,” says Paul Dunn, pharmacist and Head of Quality at Rokshaw Labs. “Therefore the emphasis is on building quality in from the very beginning of the process. This includes using only approved suppliers of raw materials and testing those raw materials to ensure quality, using suitably qualified staff such as pharmacists to formulate safe products and perform a final quality check post manufacture in a clean room facility.”
Special medicines potentially carry a greater risk than compared to prescribing a licensed medicine. Therefore, patients need to be supported by their pharmacist to ensure they understand the manufacturing process and how to use specials effectively. Since Patient Information Leaflets aren’t available for specials, it’s important that patients understand why they are taking their medicine, how to take it and about any potential side effects or drug interactions.
“We explain to patients that specials are often unlicensed medicines and they’re not made for everyone, which is why it may take longer to source them,” says Thorrun Govind. “We make them aware that their doctor has decided after their consultation that this medicine will benefit them, taking into account the risk-benefit ratio, but it may not have been tested routinely on people, or for the reason they are taking it. Taking the time to explain everything ensures the patients trusts the pharmacist.”
Specials versus specially obtained items
According to the Royal Pharmaceutical Society (RPS) Prescribing Specials guidance issued in April 2016, specials can be difficult to identify at the point of prescribing. Only unlicensed products are endorsed as specials, even if they are being ordered from a specials supplier. Otherwise, they will be classified as ‘specially obtained items’, such as appliances, nutritional supplements and gluten-free foods.
It’s important that pharmacists know the difference between specials and specially obtained items, so that the prescription can be endorsed correctly. There is a video about this on the NPA website, with Leyla Hannbeck, head of pharmacy services: https://www.npa.co.uk/news-and-events/npa-tv/specials/. NPA Members can also access a free online training module on the Specials tariff which includes sections on endorsements – broken bulk, specials listed in the specials tariff and brand prescribing of specials products.
Key questions to ask suppliers
Catherine Brown, commercial director at Quantum Pharmaceutical, recommends asking these questions:
1. How many audits are conducted each year on your supply base?
2. How many quality checks do each of the manufactured lines pass through during the manufacturing process?
3. How many trained pharmacists and technicians are employed?
4. How many people are there in the customer service team to help process my order or query?
5. Who do I contact in the event of a technical query or pharmacovigilance issue?