APSM

But specials scripts are not increasing says APSM One year after the introduction of the Specials Tariff, the APSM (Association of Pharmaceutical Specials Manufacturers) reports that the Tariff appears to have been successful in restoring confidence to the market, but says there is little evidence to date that this is having a positive impact on prescribing levels. A poll of pharmacists by Opinion Health showed that almost half are happier prescribing specials now that a tariff is in place.   But although latest figures from NHS Prescription Services show a gradual increase in the number of specials ordered month-on-month from November to June, the APSM challenges any interpretation that this is a sign of growth.   It is more likely a reflection of improved reporting by pharmacists and the DOH where prior to the Tariff, special scripts were frequently classified as ‘other’ rather than ‘unlicensed medicines’.   Says Sharon Griffiths, Vice Chair of the APSM,...

QUALITY PROCESSES FOR UNLICENSED MEDICINES Unlicensed medicines, or specials, are only offered to a patient when the physician has identified a clinical need that cannot be met by any available licensed alternative.   In the UK, the majority of specials are manufactured and prepared by Specials manufacturers who are licensed, regulated and inspected by the MHRA and must comply with the principles of Good Manufacturing Practice (GMP) adopted by the EU Commission.   These licensed manufacturers provide additional assurances of quality.   A certificate of analysis is provided for batch manufactured specials as evidence that critical parameters have been met through physical, chemical or microbiological analysis of the final product.   Where individual or bespoke specials are prepared, the manufacturer will provide a certificate of conformity to show that the product meets the specification. In addition, (ALL) APSM members voluntarily undertake to apply th...

The APSM (Association of Pharmaceutical Specials Manufacturers) recently conducted a survey of pharmacists which showed that nearly half* of pharmacists felt more comfortable dispensing specials now the tariff is in place.  This is a positive response, but the APSM believes there is more work to be done to ensure the long term effectiveness of the Specials Tariff as a means of supporting a viable Specials sector.  In the past two years there has been a lot of focus on cost and even though the tariff is in place, this is continuing with pressure from PCTs to reduce spend.  The APSM is concerned that this ongoing pressure on cost could impact on quality if those involved in prescribing and dispensing specials do not have sufficient knowledge to make value-based decisions about patient need and quality.  The APSM believe that there is a need for greater education and support for those with responsibility for patient safety and they need to be supported in ...

15 th NOVEMBER 2011 The ACSM has changed its name to the Association of Pharmaceutical Specials Manufacturers (APSM) to reflect the clinical nature of its members’ products and services. As the trade association representing the interests of companies involved in the manufacture of unlicensed medicines, the role and importance of the APSM has grown in recent months as the organisation has provided a conduit for information and advice to the DH in the lead up to the Specials Tariff (published this month).   Specials account for around 1% of the prescription budget but this can be made up of more than 75,000 different formulations – each designed to meet the specific need of a patient where a licensed medicine is not available.  Said APSM Chairman, Alan Krol, “Specials serve a vital clinical need, it really is tailored and personalised medicine in every way – no other pharmaceutical manufacturer gets closer to the patient.” Said APSM Vice Chair, Sharon Griffiths...

Please click here to view the article published 10th November 2011.

Initial reaction to THE SPECIALS TARIFF is that it appears to reflect the input given by Specials manufacturers to the DH and the ACSM has welcomed its introduction.  Speaking on behalf of the ACSM (Association of Commercial Specials Manufacturers), which represents 80% of specials manufacture in the UK, Chairman, Alan Krol (pictured left) said, “Over the last two years our members have worked closely with and provided data to the DH about pricing and volumes and we hoped this would be reflected in the tariff.  Although we have only just received the Tariff, we believe that it does represent much of our input and we are all now looking forward to putting it into practice.” However the ACSM caution, it will take time to fully understand the full impact of the Tariff.  It has been a complex process, so no one can be certain yet if there will be any impact on the quality and continuity of supply, even though in the short term it will do much to restore confidence in the...

News article published 12 October 2011 by the NHS Business Services Authority Website. 'New arrangements for reimbursing specials - Q&A' and also for the 'Proposed Specials Tariff to be published November 2011' have been published. Please click   here to view the documents.