Layer 1

How you get your specials

How are specials produced? Manufacturers explain the process from setup to delivery

Click on a phase for more information:
All images courtesy of Quantum Pharmaceuticals

Case study: Dealing with a 'special' prescription

You receive a prescription for omeprazole oral suspension 10mg/5ml for a 10-month-old child but there doesn’t seem to be a licensed product available. What should you do?

Leyla Hannbeck, head of pharmacy services, NPA

This prescription isn’t that unusual. In clinical practice, omeprazole is sometimes used off-licence in children under one year. Recommended doses are available in the British National Formulary for Children (BNFC). To calculate the suitable dose, the child’s weight should be recorded as below.

Omeprazole dosage by mouth (BNFC)

Neonate

700 micrograms/kg once daily (max 2.8mg/kg)

Child one month to two years

700 micrograms/kg once daily (up to 3mg/kg; max 20mg)

10-20kg bodyweight

10mg once daily. The dose can be increased to 20mg once daily if needed (for a maximum of 12 weeks in severe ulcerating reflux oesophagitis)

> 20kg bodyweight

20mg once daily. The dose can be increased to 40mg once daily if needed (for a maximum of 12 weeks in severe ulcerating reflux oesophagitis)

The problem is that omeprazole oral suspension is available only as an unlicensed preparation. This means you will have to calculate whether that is the right course of action. The pharmacist should first confirm with the prescriber that an unlicensed product is required because it will be their decision whether it should be supplied. As the pharmacist, you will need to be sure, too.

The British National Formulary 69 says the MHRA recommends thatan unlicensed medicine “should only be used when a patient has special requirements that cannot be met by use of a licensed medicine”. Pharmacists should supply medicines based on the risk hierarchy criteria outlined by the MHRA:

Where a UK licensed product exists, this must be supplied

Use of a UK licensed product off-label, for example, for an unlicensed dose or indication, is preferable to prescribing an unlicensed special

If a UK licensed product is not available, then an unlicensed foreign medicinal product should be sourced – this product will have undergone rigorous testing as part of the licensing procedure in the country of origin

If none of the above are available, then an unlicensed product may need to be manufactured by a UK manufacturing company. 

Once the pharmacist is satisfied that a special should be supplied, they should check whether their usual wholesaler can supply the product. If not, the pharmacist should refer to the BNF list of special-order manufacturers and order the unlicensed product directly. The pharmacist should be aware that part VIIIB of the Drug Tariff (England and Wales) contains a list of some unlicensed products and the price that will be paid for reimbursement of these products. It means that pharmacies need to source the product for no more than the Drug Tariff Part VIIIB price (if listed in part VIIIB) because this is the reimbursement price the pharmacy will be paid. Alternatively, omeprazole 10mg/5ml suspension can be prepared extemporaneously. 

When dispensing the suspension, the pharmacist should supply an oral syringe and ensure the patient’s parent/representative is comfortable measuring the correct dose. They should also be made aware of any specific storage requirements and side effects, which may include nausea, vomiting, flatulence, diarrhoea or constipation. Less frequent side effects include dizziness, sleep disturbances and rash.

As with any medicine, it is important to review the continued need for proton-pump inhibitor (PPI) use. There have been reported risks associated with long-term use of PPIs. If there is a need for continued use, ie the child continues to be symptomatic, dose escalation of the PPI may be required as the child gains weight.

0 Comments
Login or register to post comments

Job of the week

Pharmacist Manager
Midlands, Cheshire & Dorset
Salary dependent upon experience