Monday, 10 September 2018

What to look for in a Specials Manufacturer

What to look for in a Specials Manufacturer

For anyone looking for a Specials supplier, this article in Independent Community Pharmacist gives some useful advice.

Or you can check out the information on our APSM website which lists the quality criteria required of holders of an MHRA specials manufacturing licence.  It also includes some of the additional services provided by APSM member companies.

APSM website

Friday, 11 May 2018

Patient experience is at heart of decision to prescribe a special

When the Royal Pharmaceutical Society (RPS) updated it’s guidance on the procurement and supply of specials1, the focus was on putting the patient experience at the very heart of the process.
The APSM supports this approach, believing that the emphasis on cost in recent years has sometimes clouded this underlying principle of a special provision.
Says the RPS Guideline, the starting point is to establish the optimal treatment for the patient, this means that if a suitable licenced medicine is not available a Special must be offered to meet the patient’s special circumstances and urgency of need for treatment.  This basic decision to supply a Special therefore, cannot be based on cost or convenience.  

Case Study:
A GP prescribed an anti-inflammatory drug in a dispersible tablet formulation for a child with arthritis. A week later the mother returned to the GP because the child was still in pain despite giving the medicine as directed. The GP found out that the child had been given 50mg dispersible tablets and parent told to dissolve these in 5ml of water then give the child 1ml to provide a dose of 10mg. Dispersible tablets are designed to provide the full 50mg dose. When dispersed in water a lot of the product fell to the bottom of the glass, so taking 1ml out of the total volume resulted in a variable dose. On testing, this ranged from between 2mg and 8mg and the 10mg required was rarely achieved. Had the child been given a properly formulated Special, their pain could have been more adequately controlled. (Adapted from Tomlin S, et al. Making medicines safe for children – guidance for the use of unlicensed medicine in paediatric patients. Berkhamsted: MGP Ltd, February 2009)

1.    Professional Guidance for the Procurement and Supply of Specials 2015.  RPS.

Monday, 13 February 2017

Specials record another year of delivering increased value to the NHS

The Specials Market in primary care was just over £80.5 million for the 12 month period Oct 15 - Sep 16.  Although the market continues to decline year-on-year, it is now stabilising following a period of readjustment in the wake of the Specials Tariff in November 2011.  During this time the mean cost per item has reduced from £180 per item before the tariff in Nov 2011, to an average £116 for the same 12 month period to Sep 2016.

Whilst this represents value for money to the NHS, at the same time the high standards of quality involved in Specials manufacture have needed to be maintained.  According to the Association of Pharmaceutical Specials Manufacturers, APSM, members report continued investment in infrastructure and quality processes to meet the increasing regulatory demands required by the sector.

To reflect the increased complexity of the market, last year (2016), the Association of Pharmaceutical Specials Manufacturers, APSM, decided to broaden its membership criteria to the wider supply chain, including importers as well as virtual Specials manufacturing organisations who own the rights to, and act as the first supplier of, a Specials medicine in the UK.
In the last 5 years following the introduction of the Specials Tariff there has been significant developments in regulatory framework and professional guidance around Specials and the role of the APSM has changed to be one of influencing and responding to issues in this changing market – always with the aim of maintaining a robust quality framework and best practice across the entire supply chain, not just manufacture. 

Said APSM Chair, Sharon Griffiths, ‘Our ultimate goal is to maintain a sustainable Specials sector that provides high quality, safe medicines to patients – we’re looking forward to working with more organisations who share this vision.’Specials Spend 2015-16

Tuesday, 6 September 2016

APSM expands membership to reflect changing role of specials industry

The Association of Pharmaceutical Specials Manufacturers, APSM, has broadened its membership criteria to include importers as well as virtual Specials manufacturing organisations who own the rights to, and act as the first supplier of, a Specials medicine in the UK.
Originally founded to represent the interests of holders of a Specials Manufacturing Licence, the APSM has an important role liaising with the DH and key policy makers as well as inputting into decisions around new legislation and Specials guidance.
The decision to broaden membership to the wider supply chain reflects the changing shape of the Specials market, particularly over the last 5 years following the introduction of the Specials Tariff alongside a developing regulatory framework and professional guidance around Specials.  Influencing and responding to issues in this changing market has also become a more important role for the APSM.
APSM Chair, Sharon Griffiths, said, “The decisions and actions we take now have implications for the entire supply chain and we need to give other organisations who have an interest in this market an opportunity to contribute to those decisions.”
Our ultimate goal is to maintain a sustainable Specials sector that provides high quality, safe medicines to patients – we’re looking forward to working with more organisations who share this vision.
For details of membership please contact the APSM Membership Director Brian Fisher via email: brian.fisher@quantunpharma.co.uk

A membership pack can be downloaded from the website www.apsm-uk.com

We welcome applications for membership from the following organisations.
·       Manufacturers of Specials medicines that operate under an MHRA Specials Manufacturing authorisation
·       Importers of unlicensed medicines that operate as first supplier of these to the UK market
·       Companies that own the rights to, and supply Specials medicines, as the first supplier to the UK market

Monday, 1 August 2016

The APSM updates website

The APSM has launched our new website which is the definitive source of information about Specials in the UK.  In addition to updated content about the role of Specials in the patient journey, there is detailed information about the regulatory framework for prescribing Specials and up-to-date market stats about the cost of Specials in the UK.

Designed for anyone involved in prescribing or dispensing Specials, the website contains lots of useful tools to support clinical understanding and decisions around the use of unlicensed medicines. There are also links to useful resources such as professional guidance and the Drug Tariff.

Says the APSM, the website is designed to promote the important role of Specials Manufacturers in helping to meet this important area of patient clinical need with high quality advice and product information.


Tuesday, 8 December 2015

APSM corrects Daily Mail article market stats

An article published today (8 December 2015)  in the Daily Mail ‘High Street Chemists who charge the NHS £300 for skin creams that should cost £12’, contains a number of significant inaccuracies about the Specials market and APSM activities.
Here follows the APSM response to the facts presented within the article.

DAILY MAIL QUOTE:  The practice has been exposed by the BAD which says up to £400m a year of taxpayers’ money is being wasted on paying too much for these treatments.  Even 2% salicylic acid cream which can be effective for these conditions costs the NHS £75m per year.

APSM Response:  Dermatology Specials are a small proportion of Specials spend in primary care – approximately £1m per year.

The total spend on Specials in England in 2014 was £89.5million in primary care.  A very small percentage of this is for dermatology specials through community pharmacy.   

Only a small number of Dermatology products are in the top 500 specials*.    In the last 3 months to September 2015, 1404 items were prescribed for topical use (which would include dermatology products) at a cost of £259,360.  Over a year this is approximately £1m. (Just over 1% of all spend).

Of the 3 products mentioned specifically, Coal Tar 5% was 220 prescriptions in last 3 months less than£200,000 per year (average cost £180 - £190).  Coal Tar 10% ointment 100g was 23 in the last 3 months – less than £30,000 a year. 2% salicylic acid in aqueous cream 100g was 63 prescriptions in 3 months - approximately £50,000 over a year.

These figures are based on data for England. The estimated value for Dermatology Specials in the community including Scotland and Wales is £1.2m (an additional 20%).

*The NHS BSA lists the top 500 most reimbursed specials (in Primary Care) by cost (NIC) and number of items.  This includes items on the Drug Tariff as well as those not included in the Tariff and covers approximately 80% of the total spend on Specials each year.

DAILY MAIL QUOTE:  In Scotland they are still supplied by NHS prices but in England the pricing is governed by market forces

APSM Response:  The Scottish Tariff covers a smaller number of products (50) and uses a different mechanism for setting prices, although commercial and NHS prices are also taken into account.  Overall, the price of the majority products on the Specials Tariff in Scotland is similar to the England Tariff with some fluctuations (some are cheaper in England than Scotland and visa versa). 

Certain dermatology products may have been negotiated separately and we cannot comment on the process used.

The Specials Tariff is designed by the Department of Health to provide sustainability of supply and a mechanism to ensure that safe and effective specials are available to the NHS via a resilient supply chain that provides a fair return, ensuring the long term sustainability of the specials market.  The DH has a mechanism for deciding which products will go on Tariff and it is regularly reviewed. 

DAILY MAIL QUOTE: “The creams are made by 14 member companies”

APSM RESPONSE: Of our 13 members only a minority produce any of these creams and in very small volumes.  APSM members report that they produce a relatively small number of specials for dermatology supply to community pharmacy.  If they are asked to produce them they are generally bespoke ‘one off’ preparations, i.e. the ingredients are sourced and they are manufactured, quality checked and sent out the same day.

DAILY MAIL QUOTE:  “in prescriptions outside hospitals, £246 - £346 for every pot used”

APSM RESPONSE: The Tariff prices listed for these products as listed in the latest Tariff dated November 2015 they are:

-      100g Coal tar 5% in oint base  - £280.96
-      2% sulphur/2% salicylic acid in aqu cream  - £198.64
-       10% coal tar oint 100g - £216.36.

Prices in English November Part VIIIB

DAILY MAIL QUOTE: These traditional ointments contain coal tar, sulphur or sometimes dissolved aspirin, in aqueous cream, a base of paraffin oils used for generations for dry skin.

APSM Response:  The product examples used are not simple, effective or high street products.
Coal Tar is a particularly difficult product to manufacture.  Although it has been used for hundreds of years in skin preparations, there are concerns about its toxicity and known carcinogenic properties both for patients and those involved in manufacturer, so it can only be manufactured under special conditions.  Pharmaceutical standard coal tar as an ingredient is now very difficult to source – due to recent changes in safety and quality regulations there are now only a very limited number of raw ingredient suppliers worldwide and the cost has become prohibitive – in fact many licenced manufacturers have had to cease manufacture.   For these reasons, it is rarely used in manufacture for licenced pharmaceuticals or Specials.

In March 2013, the MHRA (Medicines and Health Regulatory Authority) issued a warning about the use of Aqueous Cream, particularly for children with eczema as it may be an irritant.  This is thought to be because of the, sodium lauryl sulfate (SLS), contained in emulsifying wax which is one of the ingredients of aqueous cream.  The National Eczema Society and NICE advise caution in its use.

DAILY MAIL QUOTE: Private manufacturers have come in as part of the drive to open up the NHS to market forces, but as a result patients and taxpayers are being penalised.

APSM Response:  Commercial manufacturers were set up in response to MHRA increased controls on specials quality and patient safety following the ‘peppermint water case’ in 2000, in which an infant died after an incorrectly formulated pharmacy preparation.  Specials are now rarely made up in a community pharmacy.  There are a small number of hospital manufacturing units which also have MHRA licences, but the commercial sector exists to meet the majority of demand.

DAILY MAIL QUOTE:  “The NHS is charged more than £300 a pot for products that could cost just £12

APSM Response: If an NHS manufacturing unit charges £12 then this reflects the price they charge, not necessarily the cost of the product – this would not be sustainable in a normal commercial environment.   The full costs of manufacture may have been allocated elsewhere within the NHS budget (staffing, capital investment, etc).   Also, for some medicines they may have been able to manufacture a batch in advance or at a later date and can achieve cost efficiencies this way, i.e. they are not always operating a same-day service. 

In England and Scotland a number of Hospital Pharmacy units are supplying Specials alongside commercial manufacturers and together we are providing essential services to patients.  However, most in-house hospital units are not geared up to large volume production across such a wide range of possible products so could not meet the demand for Specials – particularly in England. Therefore the majority of capacity and volume in the market comes from the commercial pharmaceutical manufacturing sector and so the cost structure of the market has to be based on a commercial rather than NHS funded model.

The Price Difference reflects the commercial model

The main purpose of Specials manufacture is to patient safety and to meet patient clinical need.  Commercial manufacturers are required (by the MHRA) to carry sufficient capacity to meet demands on a daily basis with more than 20,000 potential preparations on systems, it is not possible to predict demand so most orders are manufactured same day.  For the average manufacturer this can be 2-500 different orders per day.  There are inherent costs involved with maintaining a high level of production capacity to fulfil orders, as well as express delivery costs.    This same-day manufacture also includes a very stringent quality process (to pharmaceutical standards) – see attached – to ensure patient safety.  The costs associated with this intensity of commercial manufacture are reflected in the price.

DAILY MAIL QUOTE: “We have tried to discuss it with the APSM but says it doesn’t have to talk to us”.

APSM RESPONSE:  “We made a direct approach to BAD over a year ago to introduce ourselves.  We attended a meeting, shared information and agreed to attend future meetings of their Specials Working Group.”

DAILY MAIL QUOTE:  “Because of a commitment to open the NHS to market forces and competition, the Government has now prevented NHS pharmacies that manufacture these creams for hospital use from also offering them through community pharmacies”

APSM RESPONSE: “Our understanding is that any hospital pharmacy with an MHRA specials licence can – and do - supply to community pharmacy.”

Thursday, 5 November 2015


The APSM, Association of Pharmaceutical Specials Manufacturers, is reminding pharmacists of the importance of 24 hour turnaround for bespoke Specials prescriptions.  All APSM members sign up to a commitment of timely delivery to patients1 and for all members that now means next day delivery as standard.   Members report that between 95-99% of orders are despatched the same day of receipt for delivery the following.
Said, APSM Chair Sharon Griffith, “What may have started as an effort to offer competitive advantage – we’re happy to say is now the norm amongst APSM members which is good news for patients.   Patients who are prescribed Specials often have a specific and urgent clinical need - they should not have to wait for this medicine just because it isn’t a licensed or off the shelf preparation.”
Although Specials manufacturers are geared towards bespoke manufacture it can still present a challenge.  With more than 20,000 potential preparations on our systems – we can’t predict what’s coming or think ‘we’ll save it and make a batch next week’.  An order is received, it is manufactured, goes through QA and is despatched all within 24 hours.  For a typical Specials manufacturer this can mean 500 different orders a day – and of course the inherent costs associated with express delivery costs and maintaining a high level of manufacturing capacity so that orders can always be fulfilled.
As ongoing medicine supply shortages result in longer waits for prescriptions, APSM is reassuring pharmacists that Specials manufacturers are continuing to meet patient need on a daily basis – 365 days a year.  Continuity of supply is being maintained in spite of the fact that Specials are unusual and account for less than 1% of all prescriptions annually. 
Said, Sharon, “We are committed to maintaining a sustainable manufacturing base for Specials in the UK and in spite of increased commercial pressure our APSM members have continued to invest in high quality infrastructure and processes.  In the last 5 years our members have collectively invested over £100m in service improvements – which is more than the value of the Specials market.

1. Members will at all times act in the interests of customers and ultimately patients with respect to the timely preparation and supply of Special medicines.  It is recognised that members frequently supply on an urgent basis and will protocols and standards to supply in accordance with such timelines.