APSM Blog

Monday, 9 September 2019

How Specials manufacturers support community pharmacists

APSM member companies dedicate their resource and expertise to this very specialist area of medicines manufacture. They are an essential partner to pharmacists and can streamline the process from assessing the formulation, through quality manufacture to timely delivery.  Most pharmacists are only called upon to dispense a handful of specials prescriptions each month.  A specials manufacturer can help pharmacists to navigate the complexities of supply and avoid issues with reimbursement. 


The following summarises the ways in which APSM member processes align with RPS guidelines1


1. 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’
A special can only be supplied when and if a licensed alternative is not available and so the very first thing a specials manufacturer will do is to check this.  APSM members report that it is quite often the case that they reject an order for this reason, instead providing the pharmacist with details of the licensed preparation.

The Guideline underlines the importance of Prescriber and Pharmacists working together to agree medication and formulation. However, the Specials manufacturer also plays an important role in this process.  As a requirement of membership, APSM members have expert and knowledgeable customer service teams whose role it is to provide advice and expertise about any aspect of a specials prescription.  

2. 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”. 
APSM companies undertake to provide clear labelling on their specials. If necessary, they can advise on alternative formulations that might be more acceptable to patients, for example, flavouring.
As a requirement of membership, APSM members have expert and knowledgeable customer service teams whose role it is to provide advice and expertise about any aspect of a specials prescription.  

3. 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.”
Quality commitment from a licensed Specials manufacturer
APSM members have invested more than £150 million in quality and infrastructure in the last 5 years.
All members should offer:
·      Premises inspected by MHRA for compliance to GMP (Good Manufacturing Practice)
·      A pharmaceutical quality assurance system, e.g. pharmacopoeial monograph, stability tests
·      Batch testing / Certificates of Analysis provided
·      Certificates of Compliance (for single products)
·      Best practice labelling
·      Customer support line
·      Unique codes on all products
·      Innovation – e.g. clearer patient labelling
·      Yellow card adverse event reporting
·      Investment in facilities for medicines manufacture

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.

Specials manufacturers have streamlined order processes to the extent that on receipt of the product request, the manufacturer manages the process through to verification of requirements, prompt delivery and provision of supporting paperwork.


4. 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.”
The APSM can support this review process, offering advice about formulations and if necessary advising if a licensed alternative has subsequently become available.



5. 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.” 
Clinical governance for the pharmacy contractor is defined as ‘about being accountable, taking professional responsibility, having the right systems and processes in place and about continuously improving what we do.’    This is very reflective of the ethos of all APSM member companies for a number of pharmacy governance processes, either directly or indirectly.  

These include:

-     Adverse events monitoring – all APSM members also monitor and report AEs

-     MURs – advice about a special, or, if there is a problem with the pharmaceutical form of a medicine, what options might be available for a special. 

-     Out of stock – is there a special alternative available that could be prescribed?

-     Special obtains – sourcing niche or difficult to obtain licensed products is often a service provided by specials manufacturers

-     Specials procurement Information about shelf-life and stability – certificates of conformity and certificates of analysis


For a list of APSM members and services provided visit Specials Suppliers


1.     PROFESSIONAL GUIDANCE FOR THE PROCUREMENT AND SUPPLY OF SPECIALS (2015). Royal Pharmaceutical Society


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. Sourcing Specials

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.

WWW.APSM-UK.COM

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.”