- 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
Why specials manufacturing was introduced?
ReplyDeleteSpecial Manufacturing was introduced when licensed medicine aren’t available. Often the formulation that would best meet the patient’s needs has not been commercially manufactured by any drug company in a licensed version. Or the licensed product needed by the patient has been discontinued. In these circumstances a Special will be prescribed.
Many licensed medicines are not developed in the correct dosage or formulation for some patients and so would be too costly for it to be commercially viable for pharmaceutical companies. This is why prescribers are given the freedom to prescribe any drug in any formulation for these patients. In some cases and for patients in hospital, these Specials are made up by the hospital pharmacy. In others, the patient can take their prescription to any pharmacist and their Special will be individually made to order for them and delivered usually the following day.
http://www.apsm-uk.com/what-are-specials.php
How this affected the amount of extemporaneous dispensing in community pharmacy?
Over recent years, pharmacists have increasingly used Specials rather than products made extemporaneously, due to the desire to ensure quality in the manufacturing process and to enhance patient safety.
A special manufacture licence guarantees that sourcing of ingredients, product development, packaging and labelling, as well as manufacturing and supply processes, are all to regulatory standards.
This licence is not required for extemporaneous dispensing, as this can be conducted in a registered pharmacy premises under the Section 10 exemption of the Medicines Act 1968. Therefore, there is no guarantee that the extemporaneous dispensing process has been subject to any formal quality assurance. Therefore it has been suggested that risks associated with extemporaneous compounding have been increased by the decreasing expertise in formulation and pharmaceutics within the profession.
The ability to dispense medicines extemporaneously has long being regarded as a skill unique to the pharmacy profession. However, one catastrophic event in the recent past, the peppermint water case, has led to considerable, ongoing debate over the safety of medicines dispensed extemporaneously. Conroy has reported the many challenges when prescribing, dispensing or administering medicines to children. A lack of information and suitable formulations leads to the need to use unlicensed and off-label products (Specials) on a regular basis.
The financial impact: Where a pharmacist contractor for some reason cannot dispense the prescription extemporaneously or elects to have it made up as a "special", the pharmacist contractor must provide to Practitioner Services Division (PSD) the reasons why a "special" was necessary. In any doubtful cases PSD, before pricing, may refer matters to the Health Board to ascertain if the additional costs involved through use of a "special" were necessarily incurred and were reasonable. Only in circumstances where the Health Board is satisfied that the use of a "special" was necessary, will the invoiced "special" price be reimbursed. In other cases, payment of ingredient costs and dispensing fees will be made on the basis that the prescription had been dispensed extemporaneously.
Royal Pharmaceutical Society. Best practice — specials. Available at: www.rpharms.com/best-practice/specials.asp (accessed 14 November 2011).
Pappas A, McPherson R, Stewart K. Extemporaneous dispensing: whatever happened to it? A survey of Australian general practitioners. Journal of Pharmaceutical Research 2002;32:310–14.
Donnelly RF, McNally M, Barry J. Is extemporaneous dispensing really in the best interest of patients? Pharmaceutical Journal, 2008;280:251–4.
Donnelly RF, McNally MJ, Barry JG Development and validation of procedures for assessment of competency of non-pharmacists in extemporaneous dispensing. International Journal of Pharmacy Practice 2009;17:67–71.
Additional Information:
DeleteWhat Impact has the introduction of special manufacturing had on the NHS financially. Since specials were added to the English Drug Tariff in November 2011, the quantity prescribed has remained relatively steady but the amount spent on them has declined by more than 30 per cent, according to the Association of Pharmaceutical Specials Manufacturers (APSM). In 2014, the amount spent on specials was £89.5m. The mean cost per item before they were added to the Drug Tariff was £179.95; now it is £122.22 – and this downward trend is continuing.
NHS Business Services Authority figures for July 2014 to June 2015 indicate that £77.9m was spent on specials in England. Put another way, that is over 728,000 items at an average cost of around £112 each. Over the same 12-month period the average net ingredient costs per item in CCGs ranged from £71.84 in Surrey Downs to £205 in Greater Huddersfield.
Specials now account for 0.95 per cent of the total NHS drugs spend of £9.4bn, with just over 500 product lines accounting for 95 per cent of specials’ spend.
Pharmacy Magazine, Dec 2014. Special effects, Are specials in danger of being viewed as expensive luxury items and not what they really are – essential medicines?
http://www.pharmacymagazine.co.uk/special-effects
Why specials manufacturing was introduced
ReplyDeleteSpecially formulated unlicensed medicines (specials) are sometimes required for patients with complex needs, such as paediatrics, the elderly, or patients who are unable to swallow hence requiring liquid formulations equivalent to the tablet form. Specials can be manufactured for the necessary supply of a rare drug for a rare disease in a small patient group, hence the basis of manufacture would be quite small, therefore the drug price would be higher. (Hopkins, R., Goundrey-Smith S., 2011)
How this affected the amount of extemporaneous dispensing in community pharmacy
An extemporaneous preparation is prepared by a pharmacist by traditional compounding techniques to produce an end product which suits the specific needs of a patient. The disadvantage of extemporaneous dispensing is that it does not undergo quality, safety and efficacy evaluation, which is done for licensed products. Which leaves room for errors to be made in preparation to go unnoticed, which could lead to potentially serious consequences. This potential for error has been reduced over the years by reducing the amount of extemporaneously prescribed medicines and increasing the amount of specials. (Pharmacy practice guidance manual, 2008)
The financial impact on NHS pharmacy services because of the introduction of specials manufacturing
The specials tariff was introduced in 2011, which has reduced the cost of specials to the NHS. (P3 Pharmacy, 2015)
The impact on patient care (risk of errors reduced?).
Many of the patients who require specials often have complex medical needs, patient safety could be compromised if a special is not selected and a alternative is used, such as the patient crushing or splitting capsules, which can be much of a higher risk to patient safety. Even though specials are a work out to be a higher cost than standard treatments, patient care is much better. (P3 Pharmacy, 2015)
when a special is required to be supplied, the following must be considered:
¥ The pharmacist must specify to the supplier what they require, the strength, formulation and excipients such as sugar or alcohol free, if relevant.
¥ Pharmacist must ensure the product is of a suitable standard, is delivered with a certificate of conformity, is appropriate and suitable for the patients needs, the shelf life is labelled and supported
¥ If further evidence can be provided from the manufacturer of the product quality, safety or efficacy.
¥ The pharmacist should supply the patient information leaflet to the patient. Verbal advice should be given if written information is not available.
¥ If the shelf life or expiry date of the product does not cover the duration of treatment, this should be notified to the patient and arrangements should be made regarding further supplies.
¥ Any adverse reactions should be reported to the MHRA via the ‘yellow card scheme’ by the patient. (“Dealing with specials”, 2010)
"Dealing With Specials". Pharmacy Professional (2010): 30. Web. Available at: http://www.rpharms.com/support-pdfs/ppjune2010-specials-june2011updatefinal.pdf [Accessed: 19 February 2017]
Hopkins, R., Goundrey-Smith, S., 2011. Specials are important and here to stay. The Pharmaceutical Journal, 287 (287). Available at: http://www.pharmaceutical-journal.com/opinion/comment/specials-are-important-and-here-to-stay/11083654.article [Accessed March 18, 2017].
Pharmacy practice guidance manual. 1st ed (2008). Dublin: The Pharmaceutical Society of Ireland. Page 30. Available at: http://www.thepsi.ie/Libraries/Publications/Pharmacy_Practice_Guidance_Manual.sflb.ashx. [Accessed: 18 February 2017)
P3 Pharmacy,. "Special Measures". P3 Pharmacy (2015): n. pag. Web. Available at: http://www.p3pharmacy.co.uk/special-measures [Accessed 19 February 2017]
"Specials Are Important And Here To Stay". The Pharmaceutical Journal 287.287 (2011) available at: [Accessed on 18 Febuary 2017].
ReplyDeleteIn recent times pharmacists have increasingly bought in specials rather than extemporaneously prepare the pharmaceutical products. This has led to a decrease in the amount of extemporaneous dispensing that occurs in community pharmacy. Pharmacists prefer to buy in specials rather than extemporaneously dispense the product to ensure quality in the manufacturing process and to enhance patient safety.
To manufacture specials in the UK a MHRA manufacturer special license is required, which guarantees; the source of ingredient, product development, packaging, labelling, manufacturing of the product and ensures that the supply is to a regulatory standard.
A special is an unlicensed medicine as the products don’t undergo a formal assessment of product safety and efficacy. A manufacturer special licence isn’t required for extemporaneous dispensing this can occur under the section 10 exemption of the medicine act. A pharmacist shares accountability when supplying a special to a patient and must therefore ensure that it is safe and appropriate.
Royal pharmaceutical society (2010). Dealing with specials. Available at [http://www.rpharms.com/support-pdfs/ppjune2010-specials-june2011updatefinal.pdf]. Accessed on 20th February 2017.
Why specials manufacturing was introduced?
ReplyDeleteSpecials are unlicensed medicinal products that are manufactured in pharmacies in the UK, for human use. They are specially prepared by a pharmacist, meeting the requirements of a prescription and do not require the manufacture to hold a marketing authorisation PSNC (2017).
The financial impact on NHS pharmacy services because of the introduction of specials manufacturing?
From 2006 until 2010 the cost of specials rose from £57 million to £160.5 million per year. This was largely due to the wholesalers inflating the prices of their unlicensed specials, in some cases up to 1000%. They were able to do this, as there is no price tariff for unlicensed specials, meaning they are able to charge what they wanted.
For example NHS Coventry reportedly paid anything from £50 to £1,556 for the blood pressure drug Captopril Liquid Special 25mg/5mls.
Another example from NHS Coventry was a pharmacy submitted a prescription charge for a specials manufacture of Omeprazole for £997, which in most pharmacies would only cost £50 Paduano (2010).
PSNC (2017). Unlicensed Specials and Imports. Online Article. Available at: http://psnc.org.uk/dispensing-supply/dispensing-a-prescription/unlicensed-specials-and-imports/ (Accessed on 20th Feb 2017). (This article contains information on what specials are, their prices payment schedules and recording requirements).
Paduano , M,. (2010). Drugs 'specials' cost NHS £160m. Online article. Available at: http://www.bbc.co.uk/news/uk-england-11376557 (Accessed on 20th Feb 2017). (This article contains information about the financial impact of specials on the NHS from 2006 to 2010).
1) why specials manufacturing was introduced
ReplyDeleteSpecials manufacturing was introduced because it could deliver higher quality and better patient safety than ordinary extemporaneous dispensing. A specials licence is required to manufacture these medications, and this ensures that the ingredients/ labelling/ manufacturing process are up to the standard level; while extemporaneous dispensing does not require any licence. (Mccague, 2012)
2) how this affected the amount of extemporaneous dispensing in community pharmacy
It decreases the amount of extemporaneous dispensing in community pharmacy because specials manufacturing ensures a standardized safety and uniformity of medications. Also, the request of extemporaneous dispensing may not be plenty enough to make training professionals time/cost-effective. (Mccague, 2012)
3) the impact on patient care (risk of errors reduced?).
Extemporaneous dispensing is preparing medication for specific patients when a suitable licensed medication is not available. One of the common occasions is when a paediatric medicine (a liquid formulation for children who have difficulty swallowing the tablet formulation) is required. The pharmacy staffs dispensing medication extemporaneously has to be trained and work accurately to avoid measuring errors or label misreading. A lack of standards and dose uniformity may lead to a contaminated/ instable/ unacceptable product for patients. (Mccague, 2012)
P. McCague, J. McElnay and R. Donnelly (2012) The Pharmaceutical Journal: What are your views on specials and extemporaneous medicines preparation? [Online] Available at: http://www.pharmaceutical-journal.com/news-and-analysis/news/what-are-your-views-on-specials-and-extemporaneous-medicines-preparation/11102745.article (It is very useful in providing information about the differences between specials manufacturing and extemporaneous dispensing.)
You have added some interesting and relevant comments to the blog. I look forward to seeing you all this afternoon when we will try some alternative methods for compounding medicines.
ReplyDeleteThis comment has been removed by the author.
ReplyDelete1: Why Specials manufacturing was introduced?
ReplyDeleteSpecials manufacturing was introduced to meet patient’s clinical needs that cannot be achieved using licensed medicines. They are prescribed by a doctor or pharmacist, and may include uncommon formulations, strengths or preservative/addictive-free products. The manufacturing of specials overcomes problems in prescribing licensed medicines. (The Specials Laboratory, 1999)
Sometimes specials manufacturing is the only option for children’s medication, sometimes routinely prescribed to provide the low doses appropriate for paediatric use. Specials are also used for patients who are unable to swallow solids and require alternative formulations such as oral solutions. (Royal Pharmaceutical Society, 2015)
2: How this affected the amount of extemporaneous dispensing in community pharmacy
The skills to dispense extemporaneous products in the pharmacy are unique and when extemporaneous dispensing competencies fall short, errors can occur, and patients’ safety and clinical care may be at risk without proper quality and preparation checking. This is illustrated by the peppermint water case. (The Pharmaceutical Journal, 2012)
In community pharmacy, there are many challenges to prescribe and prepare products for paediatric administration, and the lack of information and appropriate preparations mean that the manufacturing of specials become more frequent. In current pharmacy practice, extemporaneous products are seen less frequently and therefore staff are not able to exercise and develop the skills and confidence required to produce specials (The pharmaceutical Journal, 2012)
Bibliography:
- The Pharmaceutical Journal (2012) What are your views on specials and extemporaneous medicines preparation? Available at: http://www.pharmaceutical-journal.com/news-and-analysis/news/what-are-your-views-on-specials-and-extemporaneous-medicines-preparation/11102745.article (Accessed: 24 February 2017).
- Royal Pharmaceutical Society (2015) Professional guidance for the procurement and supply of specials. Available at: http://www.rpharms.com/support-pdfs/rps---specials-professional-guidance.pdf (Accessed: 24 February 2017).
- The Specials Laboratory (1999) Specials pharmaceuticals. Available at: http://www.specialslab.co.uk/info14-The-Specials-Laboratory,-Special,-unlicensed-medicinal-product,-.html (Accessed: 24 February 2017).
1: Why Specials manufacturing was introduced?
ReplyDeleteSpecials manufacturing was introduced to meet patient’s clinical needs that cannot be achieved using licensed medicines. They are prescribed by a doctor or pharmacist, and may include uncommon formulations, strengths or preservative/addictive-free products. The manufacturing of specials overcomes problems in prescribing licensed medicines. (The Specials Laboratory, 1999)
Sometimes specials manufacturing is the only option for children’s medication, sometimes routinely prescribed to provide the low doses appropriate for paediatric use. Specials are also used for patients who are unable to swallow solids and require alternative formulations such as oral solutions. (Royal Pharmaceutical Society, 2015)
2: How this affected the amount of extemporaneous dispensing in community pharmacy
The skills to dispense extemporaneous products in the pharmacy are unique and when extemporaneous dispensing competencies fall short, errors can occur, and patients’ safety and clinical care may be at risk without proper quality and preparation checking. This is illustrated by the peppermint water case. (The Pharmaceutical Journal, 2012)
In community pharmacy, there are many challenges to prescribe and prepare products for paediatric administration, and the lack of information and appropriate preparations mean that the manufacturing of specials become more frequent. In current pharmacy practice, extemporaneous products are seen less frequently and therefore staff are not able to exercise and develop the skills and confidence required to produce specials (The pharmaceutical Journal, 2012)
Bibliography:
- The Pharmaceutical Journal (2012) What are your views on specials and extemporaneous medicines preparation? Available at: http://www.pharmaceutical-journal.com/news-and-analysis/news/what-are-your-views-on-specials-and-extemporaneous-medicines-preparation/11102745.article (Accessed: 24 February 2017).
- Royal Pharmaceutical Society (2015) Professional guidance for the procurement and supply of specials. Available at: http://www.rpharms.com/support-pdfs/rps---specials-professional-guidance.pdf (Accessed: 24 February 2017).
- The Specials Laboratory (1999) Specials pharmaceuticals. Available at: http://www.specialslab.co.uk/info14-The-Specials-Laboratory,-Special,-unlicensed-medicinal-product,-.html (Accessed: 24 February 2017).