• details of any suspected adverse reaction to the product so sold or supplied of which the person is aware or subsequently becomes aware.
(b) Make these records available for inspection by the licensing Authority.
As a special/unlicensed medicine does not have a Marketing Authorisation, it is important to keep more detailed records of the supply. for UK manufactured Specials this should include Certificates of Analysis or Conformity and for imported Specials may include Summaries of Product Characteristics and Patient Information leaflets (translated if not already in English) 6
EnDoRSEMEnt of PRESCRIPtIonS foR SPECIAlS Unlicensed medicines are zero discount and, where the product has been sourced from a supplier holding a MHRA specials or importers licence, prescriptions must be endorsed with invoice price less discount/rebate 7
You must also submit the invoice, or a legible copy to BSo with the prescription form. It is important to try and source the special at the most competitive price available. Care must also be taken with regards to any out of pocket fees, be it handling fees or extra delivery charges, as there is no guarantee that the BSo will reimburse you for these.
If there are any doubts regarding the payment or endorsing of a prescription for a special medication, it would be advisable to contact the BSo directly. At the moment it is relatively straightforward to claim for specials but it is important to be vigilant of any changes that may occur.
SUMMARY of ACtIonS foR PHARMACIStS As pharmacists we must be vigilant when it comes to dispensing prescriptions for specials. the Royal Pharmaceutical Society (RPS) guidance recommends five principles of procurement and supply of specials (see table 1) and it would be good practice to use this as a template.
It is important that we alert the prescriber to the unlicensed nature of
the medicine and also the cost as they may be unaware that the product is an unlicensed special.
If there is a suitable alternative licensed product then this should be suggested, including the use of an alternative drug from the same therapeutic class as the initially suggested product. this may exist in a form which is more suitable for the patients’ needs.
If the prescriber is content to go ahead with the ordering and supply of the special then it is advisable to source the special at a competitive price. the prices for specials can vary greatly from manufacturer to manufacturer.
Also, a written Standard operating Procedure (SoP) should be in place, detailing the steps involved in the ordering of specials, including risk assessments of the different options available.
finally the main thing as pharmacist is to always put the patient’s care first. Is the special unlicensed medication the best possible option for each individual patient? the important thing is to work together with the prescriber to ensure the patient gets the best possible care and treatment should be reviewed regularly with a view to prescribing the licensed product. •
Bibliography 1. Specials, IPS. http://ipsspecials.com/pharmacy/About-
Us/Specials-Special-obtains. [online] 2. 15, nI formulary- newsletter Sept. http://niformulary.hscni.net/Prescribingnewslett
ers/PDf/nIMM_2015/nIMM_newsletterVol6Sup plementSept15.pdf. [online] 3. forms, RPS guidence- Splitting dosage. https://www.rpharms.com/support-
pdfs/pharmaceuticalissuesdosageformsjune-20 11.pdf. [online] 4. 1987, Consumer Protection Act. Consumer Protection Act 1987. 5. 8, MHRA- guidence note 14 section. https://www.gov.uk/government/uploads/syste
m/uploads/attachment_data/file/373505/the_s upply_of_unlicensed_medicinal_products__spe cials_.pdf. [online] 6. guidence, RPS Specials Professional. http://www.rpharms.com/support-pdfs/rps---
specials-professional-guidance.pdf. [online] 7. 17, nI Drug tariff feb. http://www.hscbusiness.hscni.net/pdf/Dt_full_f
Establish the optimal treatment for the patient
All treatment options are evaluated. Prescribers and pharmacists work together to ensure that specials are only supplied when the patient has a special clinical need that cannot be met by an available licensed medicine (this special clinical need does not include reasons of cost, convenience or operational need).
Understand the patient’s experience and make a shared decision
the patient’s needs, values and preferences are discussed to ensure that the implications and practicalities of supplying and using Specials are understood, and that patients (or carers) are supported to adhere to their medicines
Identify a preparation and a supplier
When procuring and supplying a special, pharmacists ensure that patients receive medicine that is of appropriate quality, is appropriate for the patient’s condition and personal circumstances, with minimal clinical risk.
Monitor the patient and review the need for a special
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 patient’s continued special clinical need.
Ensure effective governance is in place
governance arrangements are in place to support the safe and effective procurement and supply of specials in order to provide consistently safe and effective specials to treat patients.
Table 2 2
Table showing example prices of some specials, and their
alternatives, from 2015 ‘Special’
Ranitidine 5mg/5ml Alternative licensed product Ranitidine 150mg/10ml (Zantac® syrup)
Prices can be up to £474 (200ml)* is the licensed product. Price: £8.29 for 300ml
Omeprazole suspension 10mg/5mL Omeprazole and lansoprazole Prices can be up to £1664 (300ml)* orodispersible tablets are licensed products. they are the preferred choice for patients (both children and adults) who cannot swallow the oral capsules. Price: £7.75 and £3.18 for 28 day supply.
* price examples as per BSo prescription data May / June 2015 for third party ‘specials’ suppliers
PHARMACY In foCUS - 49
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