New guidance on prescribing specials from the Royal Pharmaceutical Society supports expert decision-making and high-quality patient care. We look at implications for pharmacy

Decisions about prescribing specials rely heavily on professional judgement based on understanding individual patient need. To reflect this, updated prescribing guidance published in June by the Royal Pharmaceutical Society remains based around five principles (discussed below). It uses case studies to illustrate particular challenges that must be met to ensure patients receive the best treatment.

As with all unlicensed medicines, the guidance says that specials should be prescribed only when there is no licensed alternative that fully meets the patient’s special clinical needs. They should be prescribed when the prescriber judges, and agrees with the patient or carer, that a special is the most appropriate option.

The guidance encourages pharmacists and prescribers to work together to ensure that prescribing is appropriate and that patients are supported to adhere to their treatment. As with licensed medicines, accountability for prescribing rests with the prescriber, but there are additional considerations for specials:

  • When prescribing a special, prescribers must be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy. Specials have not been assessed by the regulatory authority for safety, quality and efficacy in the same way as licensed medicines
  • Specials can be obtained from a range of sources by pharmacists, and are not all manufactured in the same way. This means that their quality, bioavailability and consistency can vary, even when the same product is prescribed 􀀀
  • It can be difficult to identify a special at the point of prescribing 􀀀
  • When prescribing, responsibility transfers from one individual to another. Ensuring safe and timely supply can present additional challenges for the prescriber and the supplying pharmacist.

This means that while prescribing a special may carry benefits, it can also be associated with more risk than prescribing a licensed medicine. The potential risk increases when care is transferred between different settings and prescribing responsibility changes. In these cases, there must be a planned transfer of information that ensures a safe, consistent and timely supply.

Procurement and supply

The Royal Pharmaceutical Society issued a separate set of guidelines on procurement and supply in December, which was based around the same five principles. Members of the Association of Pharmaceutical Specials Manufacturers (APSM) have already put practices in place that reflect and support December’s guidance, says APSM chair Sharon Griffiths.

All APSM member companies have customer service helpline teams and pharmaceutically trained specialists, for example. Their role is to provide advice and support on all aspects of supply and manufacture, and this aligns closely with RPS guidance, says Ms Griffiths. For example, a supplier may recommend an alternative formulation or advice if a licensed alternative is available.

It is important to note that the pharmacist does not act alone when supplying specials, says Ms Griffiths. The prescriber and the manufacturer are also involved, and there is frequently communication between pharmacist and prescriber, and between pharmacist and the manufacturer. The most recent APSM survey showed that pharmacists are most likely to refer to a prescribing doctor for advice about a specials prescription.

Manufacturer support

Quantum Pharmaceutical supports pharmacists with the Royal Pharmaceutical Society’s procurement and supply principles relating to “identifying a preparation and supplier” and “ensuring effective governance is in place”, says Catherine Brown, commercial director for the company’s specials division.

“Our advice to a pharmacist would be to ensure that where a special is deemed suitable for a patient by the doctor, they choose a supplier who can provide quality, speed and convenience a well as documentation that enables them to adhere to set regulations.”

In relation to quality, Quantum offers the highest standards so pharmacists can be confident in its products, says Ms Brown.

“Rigorous quality control underpins the internal manufacturing process and we run up to 150 checks in the production of each special to ensure patient safety. We’re proud to run a tight ship that we feel exceeds the industry norm, and we welcome the chance to take our customers behind the scenes.”

Ordering protocol

The MHRA recently contacted the GPhC about concerns that pharmacists are not confirming specials orders placed over the phone in writing, increasing the risk of a transcription error. To avoid such errors, the MHRA requires manufacturers to obtain written order confirmation, for example by email, fax or an online ordering system. RPS guidance on procurement and supply also recommends that, when necessary, the prescribed formulation should be agreed with the manufacturer in writing.

However, pharmacists do not work in this way, says Ms Griffiths. They prefer to talk to a customer services representative or formulation expert for guidance and immediate confirmation of the order. In addition, as soon as the order is confirmed, the manufacturer has to begin preparation in order to deliver within the expected time frame – usually 24 hours. Mandatory written confirmation could delay the tight turnaround time.

In most cases a written request is not essential, says Ms Griffiths.

“Specials companies train their customer services staff in processes and procedures to ensure that the special clinical needs are understood and correctly identified. The effectiveness of this part of the quality system of each member company can be, and often is, verified during regulatory inspection.

“While APSM members would be happy to receive all orders in written form, the expectation from our customers is that telephone orders are the preferred method, because this has proved to be the most efficient and satisfactory service.”

Advice on selecting a specials supplier from Quantum Pharmaceutical’s Catherine Brown 􀀀

  • Consider the length and breadth of a manufacturer’s experience – how long has it been in the industry and what products has it handled? 􀀀
  • Assess whether facilities have been inspected regularly by the MHRA to guarantee that quality, safety and efficacy are at the highest standards 􀀀
  • Ask about staff qualifications and experience, training of personnel, and standard operating procedures 􀀀
  • Check whether certificates of analysis (CoA) and certificates of conformity (CoC) are provided as a minimum.

Five principles for prescribing specials

1. Establish the optimal treatment for the patient

All treatment options are evaluated. Specials should be prescribed only 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.

2. Understand the patient’s experience and make a shared decision

Prescribers discuss the patient’s needs, values and preferences to ensure that the implications and practicalities of treatment options are understood. Specials prescribing is a shared decision and patients are supported to adhere to their medicines.

3. Identify medicines and preparations

The risks and benefits of using a special vary between different patient groups, medicines and individual circumstances. Prescribers need to take into account the safety, efficacy, quality and cost of the different products available.

4. Monitor and review

The appropriateness of continued prescribing is reviewed to ensure that it remains the best option, and ongoing supply is justified by the patient’s continued special clinical need.

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.

Pharmacists’ perspectives on specials

The specials market is not as competitive as it used to be: “We have a few patients who require specials, but the numbers are quite low and we have seen a decline in recent years. Of course, specials are tightly controlled due to cost and the fact they are unlicensed. The specials market is not as competitive as it used to be, and we find our suppliers through our buying group. We look for an equivalent licensed product first. In Scotland, we have to go through the health board for ordering, which is always reluctant because these medicines are unlicensed, expensive, and also carry handling costs.”

Fiona McElrea, pharmacist, Whithorn Pharmacy, Whithorn

Pharmacies can lose out on reimbursement: “I think there needs to be more of a combined, collaborative responsibility for specials prescribing. My main issues are safety and cost. Because these medicines are unlicensed, you have to be very sure that everything is correct. That can involve phoning the surgery to check, because it’s not in the BNF, and I’ve had to contact the NPA on a couple of occasions when the doctors were not sure. Sometimes pharmacies are losing out on reimbursement; there’s a balance between giving the customer what they need and our need to be paid correctly. It can be frustrating dealing with the paperwork. It would be much easier if you could do everything on the computer.”

Rena Dadra, pharmacy manager, Village Pharmacy, London

 

 

While prescribing a special may carry benefits, it can also be associated with more risk than prescribing a licensed medicine

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