- why specials manufacturing was introduced
- how this affected the amount of extemporaneous dispensing in community pharmacy
- the financial impact on NHS pharmacy services because of the introduction of specials manufacturing
- the impact on patient care (risk of errors reduced?).
As you carry out your research you may also find other factors for consideration so please feel free to add any comments that you think may be important and/or interesting
The drug tariff defines a ‘special’ as ‘an unlicensed medicinal product manufactured in the UK for human use which have been specially prepared to meet a prescription ordered for individual patients without the need for the manufacturer to hold a marketing authorisation for the medicinal product concerned.” (PSNC, 2016) Specials’ account for approximately 1% of all prescriptions in the UK, but account for more than 75,000 different formulations. Specials, like all unlicensed medicines, should only be prescribed when there is no available licensed medicine which fully meets the patient’s special clinical needs. They can be prescribed when it is judged by the prescriber; and agreed with the patient or carer that, on the basis of available information, the use of a Special is the most appropriate option for the patient. Examples of appropriate use of specials include, allergy to particular excipient, nasogastric tube use, or unsuitable for children preparations. (APSM, 2016)
ReplyDeleteSpecials manufacture has grown massively since 2000, with community pharmacists buying in specials that would have previously been made extemporaneously in the pharmacy; this has become more popular to ensure quality and safety in manufacture. It has also grown due to the changing pressures in a community pharmacy, with pharmacists being expected to do many more scripts in a shorter period of time. However it is important to consider the extra stress of finding an appropriate but cheap supplier and the need to advise prescribers so it may not be as easy as made out.To manufacture specials, the manufacturer must hold a manufacturer Specials Licence granted by the licensing authority, to attain this licence the site of manufacture must be inspected, they must comply with set guidelines by the MHRA and must be assembled by a suitably qualified person. (MHRA, 2014)
With regards to the change to the NHS finances, initially, as specials manufacturing grew it did cost the NHS a lot more than once expected, however upon the introduction of the specials tariff in November 2011 this set out strict guidelines which made it a lot easier for pharmacists to focus on a quality supplier. The NHS calculates that the specials tariff has reduced overall specials costs by 25 per cent since its introduction. (Weinbren, 2013) However to be considered is that some patients have been instructed to crush their tablets in order to avoid a specials manufacturer, which has led to incorrect dosing and unfortunately in some cases, hospitalisation, this is obviously more costly than the special item in the first place; so risk-benefit must be considered when GP’s limit their ‘specials’ prescribing.
Finally, on the safety front, specials manufacturer ensures safe products are made, quickly and as their sole responsibility is manufacture of those products with trained professionals they are less likely to make errors in formulation. Overall I would say the growing importance of specials manufacture is a good thing, as not only are we helping the patients that need the special preparation to have more efficacious treatment, we are aiding the pharmacist in lowering the workload on the extemporaneous front.
A good article with regards to the finance/costing of specials products is this one from the PSNC, it is clear and concise with a Q&A section that helped me understand it more. http://psnc.org.uk/wp-content/uploads/2013/07/Dispensing-Factsheet-Unlicensed-specials-and-imports.pdf
Refs
Association of Pharmaceutical Specials Manufacturers. (2016). What are Specials?. Available: http://www.apsm-uk.com/what-are-specials.php. Last accessed 20/02/18.
MHRA. (2014). The supply of unlicensed medicinal products (“specials”). Available: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/373505/The_supply_of_unlicensed_medicinal_products__specials_.pdf. Last accessed 20/02/18.
PSNC. (2016). Unlicensed specials and imports. Available: http://psnc.org.uk/dispensing-supply/dispensing-a-prescription/unlicensed-specials-and-imports/. Last accessed 20/02/17.
Your blog is very good, and i also agree with your point about the growing importance of specials in the UK. I also agree that the special manufacturing is a very good idea for pharmacists in lowering the work load and pressure in both community and hospital pharmacy. But do you agree that the cost of the specials compared to UK QA/QC manufactured medicines is justifiable?
DeleteThis was why the specials tariff was introduced, so that any medicines not falling within section VIIIB would not be reimbursed by the NHS. The aim of doing this was to discourage prescribers from unnecessarily prescribing unlicensed medicines, particularly where a licensed alternative was available. This would also, hopefully, encourage pharmacists to recognise where a licensed product could be given instead of a special, and speak to the prescriber to rectify this. It also allows the NHS to choose the prices that they are willing to pay for high demand specials, deterring healthcare professionals from expensive specials that they will not be reimbursed the full cost of.
DeleteSpecials are defined as unlicensed medicinal products which are prescribed outside of the terms of their UK or EU valid licence, or for which no licence was issued. With the decline of extemporaneous dispensing and the developing legislation regarding good manufacturing practice, prescribers are advised to give preference to medicines with a marketing authorisation. However as health conditions become more complex and challenging to treat, prescribers may sometimes select products outside of their licence. This is usually done at the discretion of the prescriber, using their medical knowledge to tailor treatment to the patient as an individual. Sufficient evidence must be gathered regarding the safety and efficacy of the medicine to support the prescribing of a special (General Medical Council, 2017).
ReplyDeleteWhilst extemporaneous dispensing is still performed in the hospital sector, community pharmacies rely heavily on specials manufacturers to prepare and supply such medicines. A certificate of analysis and/or conformity is delivered with the special, and must be retained for a minimum of five years. These documents detail those involved with the manufacture of the medicine, analytical test results for the special and a written declaration that the product fits the specification. The strict procedures and regulations followed throughout production of specials would be difficult to replicate in the busy environment of a community pharmacy. The greater guarantee of safety and quality, and also reduced liability of community pharmacists, make specials manufacturers a more popular choice for obtaining unlicensed medicines. Pharmacists are still required to ensure the product is visibly of suitable quality, and that the correct documentation is supplied and stored appropriately in case of a discrepancy (Royal Pharmaceutical Society, 2011).
The cost of sourcing specials from third parties placed increasing strain upon the NHS. With greater dependence upon specials manufacturers, prices naturally increased to reflect this. This meant that the NHS were originally expected to reimburse these increasing prices, up until the introduction of a specials tariff. This details a list of set prices that the NHS will reimburse (under section VIIIB), regulating prices and leading to a reduced cost per item. The aim of this was to limit excessive purchasing and prescribing of specials. However this implementation of a tariff made clear that choosing between extemporaneous dispensing in the pharmacy and third party specials manufacturing was a difficult choice for the NHS. It is clear that both have their advantages and disadvantages in terms of cost-effectiveness and safety (APSM, 2015). Guidance by the Royal Pharmaceutical Society (2015) places extemporaneous preparation under supervision of a pharmacist at a higher risk level than manufacturers holding a specials (MS) licence. The MHRA regulates MS licence holders and their premises, giving more opportunity for error in processes, contamination and QA/QC issues to be detected. Preparation of specials in the pharmacy usually occurs under strict time constraints, placing increasing pressure on staff. Oversight of the smallest detail can occur due to pressure, lack of experience, inadequate SOPs on extemporaneous dispensing or misreading of instructions/measurements. This increases the risk of errors drastically, particularly in a setting where the pharmacist has such a short space of time to prepare the item. The use of specials manufacturers gives a safer and strictly regulated approach to extemporaneous dispensing. Following incidents such as the peppermint water case it is easy to see why community pharmacists would prefer this option, and why preparation of unlicensed products in the pharmacy has declined. However the financial burden on the NHS should give more incentive to give preference to licensed medicines available, and view specials as a last resort.
References:
DeleteAPSM. (2015). How specials can delivery value to the NHS without compromising patient safety. Online reference. Available from: http://www.apsm-uk.com/files/whitepaper.pdf (Accessed on 21 February 2017). (Description of the specials tariff and its impact on NHS finances).
General Medical Council. (2017). Prescribing Guidance: Prescribing Unlicensed Medicines. Online reference. Available from: http://www.gmc-uk.org/mobile/14327 (Accessed on 19 February 2017). (Defined specials and guidance on their use for prescribers).
Royal Pharmaceutical Society. (2011). Dealing with Specials. Online reference. Available from: http://www.rpharms.com/support-pdfs/ppjune2010-specials-june2011updatefinal.pdf (Accessed on 19 February 2017). (Described the role of the pharmacist in ordering specials, and the documentation that is provided for an order).
Royal Pharmaceutical Society. (2015). Prescribing Specials: Guidance for the Prescribers of Specials. Online reference. Available from: http://www.rpharms.com/support-pdfs/rps---specials-professional-guidance.pdf (Accessed on 19 February 2017). (Risk levels of extemporaneous dispensing in the pharmacy compared to by an MS licence holder).
You have made very interesting and valid point here Lauren, I have understood your points and believe that the decrease in extemporaneous dispensing is due to the poor practice seen in community pharmacies over the years, not excluding relevant legislation changes due to cases such as the Peppermint Water Case. I also believe that the decline in community extemporaneous dispensing is due to the increase number of specials being prescribed to the patient due to their differential needs.
DeleteWell done Jennifer and Lauren for your contribution. Have any other members of the group found information about the subject?
ReplyDeleteMedicinal products require a product licence or a market authorisation before being brought to market, however there are instances when medicinal products are exempt from this. An unlicensed medicinal product may be supplied to meet the special requirements of an individual patient, this is known as specials manufacturing. ‘Specials’ have to be manufactured and assembled by a manufacturer holding a Specials licence issued by the licensing authority (MHRA, 2014). An example of this is if a doctor prescribes an unusual concentration of salicylic acid a white soft paraffin preparation for a specific patient. Due to the unusual formulation of the product there will be no licensed product ready to supply, to solve this a specials manufacturer will produce and supply the product.
ReplyDeleteHistorically many of these products would have been made extemporaneously upon receipt of a prescription from the doctor, however we have seen a major shift away from this in the last few decades. Specials manufacturing has made access to these types of medicines a lot easier, for example previously you would need to store the constituents of the formulation and replace them when they expired, whereas now you can order a product and within a week or two the product will be shipped to the pharmacy ready to be supplied.
Overall the errors associated with extemporaneous dispensing have decreases since the implementation of specials manufacturing. Specials manufacturers can keep a wider range of constituents and have trained professionals that regularly make special products. This leads to less errors occurring from the use of out of date ingredients or errors when formulating the products.
Like any new industrial sector the cost spent on specials manufacturing initially rose, however this was solved by the introduction of the specials tariff in 2011. This introduced new reimbursement arrangements in the aim of creating a clearer system and reducing the overall cost on the NHS. Overall pharmacies have been able to spend less on extemporaneous dispensing, since there is no need to keep ingredients in stock, and they have been able to outsource the work to specials manufacturers who can produce these products cheaper.
Reference:
MHRA. (2014). The supply of unlicensed medicinal products (“specials”). Available: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/373505/The_supply_of_unlicensed_medicinal_products__specials_.pdf. Last accessed 24/02/17.
Unlicensed medicines are available from ‘special-order’ manufacturers and specialist-importing companies; the MHRA maintains a register of these companies, and thus laboratories and companies need to Marketing Authorisation License before medicines are introduced to the market (Evidence.nhs.uk, 2017). Specials are prescribed outside the UK, and with the decline of extemporaneous dispensing due to concerns of poor practise within community pharmacies and so prescribers from their practice may select medicines that are not from the UK and may prescribe specials due to the increase number of diseases a patient may be presented with. It may also be used as the brand from the UK may be discontinued.
ReplyDelete‘Specials’ differ from the vast majority of normal medicines at a pharmacy that need to be licensed before they are available. As some patients have special clinical needs which cannot be met by a licensed product in their local area or in the UK, therefore the law allows the manufacture and supply of unlicensed medicinal products (known as Special pharmaceuticals) subject to certain conditions, which help meet individual patient needs (Specialslab.co.uk, 2017).
Due to the decrease of extemporaneous dispensing in community pharmacy due to relevant changes made by the Peppermint water case it seemed that getting cheaper medicines outside the UK has further seen the decline of exempt products and dispensing. The fact that that the specials are made in a different country it still abides with the safety regulations expected from MHRA and so it ensures that medicines produced are clinically safe and effective. There is a larger quality control and quality assurance levels seen in the Special’s manufactures than in extemp products. The PSNC states that for unlicensed specials or imports where the item is not listed in Part VIIIB in the Drug Tariff, and where the product is obtained from a manufacturer under an MHRA specials licence, the pharmacy is required to endorse the invoice price of the product to allow correct reimbursement to be made to the pharmacy (PSNC, 2017).
Mentioning the NHS, it seems that the increase use of Special medicines was expensive and so the Drug Tariff was later introduced to help solve the solution of NHS budget and reducing financial pressure within the NHS and the government (PSNC., 2017). The Royal Pharmaceutical Society supports both pharmacists and carers to ensure the safe and appropriate procurement and supply of Specials. Optimising the treatment of all patients for whom no suitable licensed medicine is available, regardless of the care setting where the patient is being treated. Due to the increase use of specials, patients are required to split doses with their formulation and so this can lead to serious consequences on their healthcare, as this action can under-dose or overdose a patient. The RPS has produced guidance to support the pharmaceutical issues to consider with crushing, opening or splitting oral dosage forms (Rpharms.com, 2016) which is really useful and is an interesting read.
References
ReplyDeleteEvidence.nhs.uk. (2017). Special-order Manufacturers : British National Formulary. [online] Available at: https://www.evidence.nhs.uk/formulary/bnf/current/special-order-manufacturers [Accessed 5 Mar. 2017].
PSNC. (2017). Unlicensed specials and imports. [online] Available at: http://psnc.org.uk/dispensing-supply/dispensing-a-prescription/unlicensed-specials-and-imports/ [Accessed 5 Mar. 2017].
Rpharms.com. (2016). Royal Pharmaceutical Society | Specials. [online] Available at: http://www.rpharms.com/pharmacy-practice-resource/specials.asp [Accessed 5 Mar. 2017].
Specialslab.co.uk. (2017). Specials Pharmaceuticals | Pharmaceutical Specials. [online] Available at: http://www.specialslab.co.uk/info14-The-Specials-Laboratory,-Special,-unlicensed-medicinal-product,-.html [Accessed 5 Mar. 2017].
Specials medicines are manufactured to meet the needs of patients. These needs are generally beyond the scope of normal manufactured products. The production of specials within the UK is overseen by the MHRA. Regulation 167 of the Human Medicines Regulations 2012 provides an exemption from the need for a marketing authorisation for a medicinal product which is supplied:
ReplyDelete1) in response to an unsolicited order;
2) manufactured and assembled in accordance with the specification of a person who is a doctor, dentist, nurse independent prescriber, pharmacist independent
prescriber or supplementary prescriber;
3) for use by a patient for whose treatment that person is directly responsible in order to fulfil the special needs of that patient; and meets the conditions specified in regulation 167 (MHRA, 2014).
These exemptions mean that products that are made tailored to a patients needs are not required to pass testing and market authorisation like large scale products need to.
Specials manufacturing within the community setting has significantly declined due to fundamental errors that have lead to patient deaths, such as the peppermint water case (2000). In this instance, a lethal amount of chloroform water was used and this lead to the death of a child. The mathematical mistake had occurred within a community pharmacy and subsequently, extemporaneous manufacturing of products was seized.
Within pharmacies now, little to no extemporaneous manufacturing is done. Children's preparations of oral medicines such as suspensions, are done within community pharmacies, but seemingly little else is. In contrast to this, hospital pharmacies do extensive amounts of preparations, such as some creams, chemotherapy bags and suspensions.
The reduction in extemporaneous dispensing within community pharmacies, to an extent, can be argued as improving patient safety, as all products that are given to patients are produced following quality standards, whereas there is a lot of scope for extemporaneously made products to vary in ingredient quantities and safety.
References:
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/373505/The_supply_of_unlicensed_medicinal_products__specials_.pdf (MHRA, 2014)
http://www.pharmaceutical-journal.com/news-and-analysis/news/what-are-your-views-on-specials-and-extemporaneous-medicines-preparation/11102745.article (Pharmaceutical Journal, 2012)
http://www.pharmaceutical-journal.com/boots-pharmacist-and-trainee-cleared-of-babys-manslaughter-but-fined-for-dispensing-a-defective-medicine/20000781.article (Pharmaceutical Journal, 2000)
A special, also known as unlicensed medicine is prescribed in the event that a licensed medicine is not suitable or available to meet the individual patient’s needs. A suitable licensed product might have not been manufactured commercially or if a suitable medication is found it could have been discontinued, in cases such as these an unlicensed alternative can be used. Specials are manufactured outside the UK and known to account for an approximate of 1% of all prescriptions in the UK and come in over 75,000 different formulations (APSM, 2015). Specials can be ordered by: Doctors, Dentists, Nurse independent prescribers, Pharmacist independent prescribers, supplementary prescribers. They may be supplied by these professionals if: there is an order that cannot be fulfilled by licensed medicine, if the product is assembled in accordance with the specification of a health professional listed above and if the product is manufactured under specific, controlled, safe conditions.
ReplyDeleteAs a result of the decreased use of extemporaneous dispensing in community pharmacies it has led to the increased use of specials in the UK. The use of specials is seen as being a much safer, effective, efficient method as the medicines prescribed as being a special must comply with the extensive safety regulations set by the MHRA. This leads to the belief that that these products are clinically safe and are prone to the errors associated with extemporaneous dispensing.
It is an expensive process to get a medicine licensed, because of this the use of specials are seen to be cost effective as these products are not used in large enough volumes or are used regularly enough to be licensed. In 2014 over £9.4 billion was spent on drugs in England and Wales, out of this £89.5 million was used on specials, which shows that specials accounted for 0.95% of all costs (APSM, 2015). NHS has been under pressure in the past to cut costs related with specials, however in the past 3 years the costs of these products has reduced by nearly 30%. As these unlicensed products must fulfil pharmaceutical standards and extensive regulations when being produced it is thought that the quality of the products would be compromised if cuts were made to the cost as lower costing products would be of less quality.
The pressures to cut costs could inevitably lead to lower quality and less safe products being prescribed to the patients. In a survey conducted using GPs 54% of them stated they had been asked by the Clinical Commissioning Group to reduce the prescribing of specials. In the same survey 45% of the GPs said they were content with prescribing a licenced product to patients and provide them with instructions to crush or split capsule or tablet medications if required. As the risks associated with crushing tablets are well known within the health industry it is believed that the pressures to reduce costs are compromising patients safety and prescribers may not dispense medications that are completely suitable or specific to the patient’s condition.
References:
MHRA. (2014). The supply of unlicensed medicinal products (“specials”. Available: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/373505/The_supply_of_unlicensed_medicinal_products__specials_.pdf. Last accessed 1st March 2017.
PSNC. (2017). Unlicensed specials and imports. [online] Available at: http://psnc.org.uk/dispensing-supply/dispensing-a-prescription/unlicensed-specials-and-imports/. Last Accessed 1st March 2017.
APSM. (2015). HOW SPECIALS CAN DELIVER VALUE TO THE NHS WITHOUT COMPROMISING PATIENT SAFETY. Available: http://www.apsm-uk.com/files/whitepaper.pdf. Last accessed 1st March 2017.