SPECIALS least five years:
• the source from which and the date on which the person obtained the product;
• the person to whom and the date on which the sale or supply was made;
• the quantity of the sale or supply;
• the batch number of the batch of that product from which the sale or supply was made; and
• 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) 5
.
ENDORSEMENT OF PRESCRIPTIONS FOR SPECIALS In respect of non-Part 7S listed items, the prescription shall be endorsed as laid down in the Generic Framework for Specials Authorisation Process across Scotland5
.
The procedure for claiming payment for a special is as follows 2 Table 1 (6)
:
Establish the optimal treatment for the patient
• You must endorse the prescription form with the invoice price of the item which has been supplied, claiming any postage and packaging incurred separately as `out of pocket’ expenses.
• Submit the invoice, or a legible copy to PSD with the prescription form.
• PSD will assess the prescription, and pay those where it is clear that the item had to be prepared by a third party and that there is no alternative route of supply.
• In all other cases PSD will pay for the ingredients and refer the script to the Board. The balance of the full cost will only be made if authorised by the Board. The Board may ask you why you chose to use a specials manufacturer for the product. Once the Board has responded, PSD will write to you informing you of the Board’s decision.
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. 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. Always check part 7S of the Drug Tariff to ensure it is reimbursable and the cost reflects the set price in the list. If there are any doubts it may be worthwhile following the Framework5
or getting
in contact with the Health Board for further advice.
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 pharmacists
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
Identify a preparation and a supplier
Monitor the patient and review the need for a special
Ensure effective governance is in place
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
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.
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.
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.
56 - SCOTTISH PHARMACIST
is to always put the patients’ 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. •
REFERENCES
1. Specials, Information Services Division Scotland- Drug Tariff Changes re.
http://www.isdscotland. org/Health-Topics/Prescribing-and- Medicines/Scottish-Drug-Tariff/ Drugs-and-Preparations-with-Tariff- Prices/docs/PCA2015-P-17.pdf. [Online]
2. Specials, Community Pharmacy Scotland-. http://www.
communitypharmacyscotland.org. uk/_resources/files/Specials.pdf. [Online]
3. 1987, Consumer Protection Act. Consumer Protection Act 1987. 4. 8, MHRA- Guidence note 14 section.
https://www.gov.uk/ government/uploads/system/ uploads/attachment_data/ file/373505/The_supply_of_ unlicensed_medicinal_products__ specials_.pdf. [Online] 5. Process, Generic Framework for Specials Authorisation. http://www.
communitypharmacyscotland.org. uk/media/92404/PCA-P-2015-17- Framework.pdf. [Online] 6. Guidence, RPS Specials Professional. http://www.rpharms. com/support-pdfs/rps---specials- professional-guidance.pdf. [Online]
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