APSM Blog

Wednesday, 23 January 2013

One year after the Tariff – Specials sector gains strength through quality


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, “Our feedback from our members and the industry as a whole is that the specials market is static at best.  We think this is partly due to reorganisation and adjustment in the market as some pharmacists review their purchasing arrangements post-Tariff.”

“However, we are concerned that this could a sign of other factors at play, notably the continued pressure by PCTs to reduce prescribing of specials.  The NHS data also shows a corresponding decrease in the overall cost of specials over the same time period.  This is in part a reflection of the effectiveness of the tariff in levelling off the pricing of specials but it could also signal a reduction in specials prescribing overall.”   Research by the APSM suggests that as many of 40% of pharmacists have been asked to reduce specials dispensing, whilst more than 50% of GPs had been requested to reduce or review prescribing patterns. 

If PCTs continue to exert pressure to reduce prescribing, the end result could be that the patient suffers because they do not receive the medication they need. 

At the moment the signs are that prescribers recognise the vital importance of specials and are keeping patient need as their top priority.   A survey amongst 200 GP’s showed that 54% had been asked by their PCT to reduce specials prescribing – although not all had decided to act on this.

Pharmacists are telling APSM members that they are also being asked to review spend on specials, but most don’t want to shop around as they are concerned that this can be time consuming and potentially risky.  Many are dispensing less than 10 specials prescriptions a month and would prefer the consistency of a specials supplier or suppliers that they know and trust.

For this reason, the APSM believes that patient need and quality is as important as overall cost and this will ensure a sustainable and high quality specials sector that can continue to invest in the infrastructure needed to ensure patient safety remains a priority.

The APSM is embarking on new educational and promotional initiatives over the coming months, working with stakeholder groups to ensure that the knowledge and tools are available to help all those involved in specials from prescriber to patient.

The APSM has recently launched a fact sheet ‘what to look for in a specials manufacturer’. 

At the same time, membership of the APSM is stronger than ever and the commitment of members is to continue to share best practice and invest in manufacturing and quality processes.  Members as a whole have invested in excess of £150m in equipment and facilities across their UK manufacturing plants in recent years. 

 

Choosing a Specials Manufacturer for Quality


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 the Yellow Card reporting scheme for their specials (unlicensed medicines).   This is the same pharmacovigilance process adopted by manufacturers of licensed pharmaceuticals.

Pharmacovigilance involves the continuous monitoring of medicines for any adverse side effects. In the UK, this process is managed under the Yellow Card scheme whereby patients, doctors and health professionals can report any potential side effects.

In this way, any adverse events related to unlicensed medicines produced by APSM members would be brought to the attention of the MHRA and therefore fully monitored and investigated in the same way as any licensed medicine.

Quality Commitment from a licenced Specials Manufacturer

ü  Premises inspected by MHRA for compliance to GMP (good manufacturing practice)

ü  A pharmaceutical quality assurance system, e.g. pharmacopoeial monograph, stability tests

ü  Batch testing / certificates of analysis provided

ü  Certificates of compliance (for single products)

ü  Best practice labelling

ü  Customer support line

ü  Unique product codes on all products

ü  Innovation – e.g. clearer patient labelling

ü  Yellow card adverse event reporting

ü  Investment in facilities for medicines manufacture