HDA UK Media and Political Bulletin – 03 February 2021

Media Summary

GSK and CureVac to develop vaccines to tackle COVID variants
Financial Times, Donato Paolo Mancini & Joe Miller, 03 February

The Financial Times reports that the UK’s GlaxoSmithKline and Germany’s CureVac will work together on a new generation of COVID-19 vaccines to tackle emerging variants of the virus that have shown some resistance to existing ones.

The two companies have agreed a €150m deal to jointly develop a product using mRNA technology that would work on multiple variants of the Sars-Cov-2 virus and could be ready for use in 2022, subject to approval.

GlaxoSmithKline will also help manufacture up to 100m doses of CureVac’s mRNA vaccine candidate at its plant in Belgium. The CureVac vaccine, the only mRNA shot that is stable at conventional fridge temperatures, is in the final phases of testing.

CureVac has said it can manufacture 300m doses of its vaccine this year, and at least 600m next year. It has signed a deal to deliver 400m doses to the EU, and has said it will no longer pursue authorisation of the shot in the US, citing market saturation.

 

Bill that could allow wider hub-and-spoke dispensing expected to become law in February
The Pharmaceutical Journal, Carolyn Wickware, 02 February

The Pharmaceutical Journal reports that legislation paving the way for wider use of hub-and-spoke dispensing is expected to receive royal assent this month.

The Medicines and Medical Devices Bill will also lay the first steps towards building a replacement for the EU’s Falsified Medicines Directive (FMD) and supporting a wider range of professions to prescribe certain medicines.

The bill’s impact assessment set out the implications “for how powers may be used in the future” following secondary legislation, which included “enabling hub-and-spoke arrangements across legal entities.” This would mean that smaller pharmacies would be able to access dispensing hubs run by larger multiple pharmacies, for instance.

The DHSC confirmed to The Pharmaceutical Journal this week that the proposed changes to the regulation of pharmacies, which would also enable hub-and-spoke dispensing, have not changed.

 

Parliamentary Coverage

House of Lords, Written Answer, 02 February

Lord Scriven (Liberal Democrat): To ask Her Majesty’s Government what is the average waiting time to receive COVID-19 vaccinations in (1) mass vaccination hubs, (2) GP surgeries, and (3) community pharmacies.

Lord Bethell (Conservative): Waiting times at individual vaccination sites are not collected centrally by NHS England and NHS Improvement. However, it is important to keep waiting times to a minimum. To support this, the national vaccination booking system has been set up so that specific time slots can be booked in advance based on a site’s capacity.

 

Oxford Coronavirus vaccine shows sustained protection of 76% during the 3-month interval until the second dose
Oxford University, 02 February

Researchers at the University of Oxford have published an analysis of further data from the ongoing trials of the vaccine. The data reveals that the vaccine efficacy is higher at longer boost intervals, and that a single dose of the vaccine is 76% effective up to 90-days post vaccination.

They report that the effect of dosing interval on efficacy is pronounced, with vaccine efficacy rising from 54.9% with an interval of less than six weeks to 82.4% when spaced 12 or more weeks apart. They also detail that a single standard dose of the vaccine is 76% effective at protecting from primary symptomatic COVID-19 for the first 90 days post vaccination, once the immune system has built this protection 22 days after the vaccination.

Professor Andrew Pollard, Chief Investigator of the Oxford Vaccine Trial said: “These new data provide an important verification of the interim data that was used by more than 25 regulators including the MHRA and EMA. It also supports the policy recommendation made by the Joint Committee on Vaccination and Immunisation (JCVI) for a 12-week prime-boost interval, as they look for the optimal approach to roll out, and reassures us that people are protected from 22 days after a single dose of the vaccine.”

You can read the full press release here.

 

Full Coverage

GSK and CureVac to develop vaccines to tackle COVID variants
Financial Times, Donato Paolo Mancini & Joe Miller, 03 February

This article is subject to copyright terms & conditions. Please access the full article here.

 

Bill that could allow wider hub-and-spoke dispensing expected to become law in February
The Pharmaceutical Journal, Carolyn Wickware, 02 February

Legislation paving the way for wider use of hub-and-spoke dispensing is expected to receive royal assent in February 2021, the Department of Health and Social Care (DHSC) has said.

The Medicines and Medical Devices Bill will also lay the first steps towards building a replacement for the EU’s Falsified Medicines Directive (FMD) and supporting a wider range of professions to prescribe certain medicines.

The bill will provide the primary legislation needed to amend a variety of legislative frameworks, including the Human Medicines Regulations 2012 (HMRs).

These frameworks were previously amended through legislation that has since been repealed under the EU (Withdrawal) Act 2018.

The bill’s impact assessment set out the legislation’s implications “for how the powers may be used in the future” following secondary legislation, including “enabling hub-and-spoke arrangements across legal entities”, which will ultimately require a change to the HMRs.

This would mean that smaller pharmacies would be able to access dispensing hubs run by larger multiple pharmacies, for instance.

The DHSC confirmed to The Pharmaceutical Journal on 1 February 2021 that, despite amendments to the bill since it was laid before parliament in February 2020, the powers enabling changes to the regulation of pharmacies to be kept up to date, which would also enable hub-and-spoke dispensing, have not changed.

It added that the bill is in its final stages and the DHSC hopes it will achieve royal assent in February 2021.

Speaking during a debate on 27 January 2021, Pharmacy Minister Jo Churchill said the government plans to hold “a full public consultation” on broadening hub-and-spoke dispensing.

“The government will then report to parliament and include a summary of the concerns raised in the public consultation,” she said.

“To ensure that we get the right model to assist pharmacy going forward, we intend to be totally transparent.”

This comes after the government also committed to consulting the public on a new national scheme to detect falsified medicines in the supply chain within 12 months of the Medicines and Medical Devices Bill receiving royal assent.

The national scheme would replace the FMD, which was introduced across the EU in February 2019 and ceased to apply in Great Britain when the Brexit transition period ended on 31 December 2020.

The bill’s impact assessment listed “introducing a scheme to combat falsified medicine products” among a range of examples of how the powers may be used in the future following secondary legislation.

The bill could also enable hospitals to use patient tissue and DNA samples to tailor treatments for individual patients and allow hospitals, in their existing facilities, to develop drugs that have a shelf life of minutes and would otherwise be unavailable to them.

Medicine manufacturers may also be required to signpost patients to “up-to-date statutory information about certain medicines on a variety of digital platforms”, rather than include hard copy patient information leaflets in packaging, under proposals permitted by the bill.

The Medicines and Medical Devices Bill was first announced in the Queen’s Speech in December 2019 amid plans to introduce legislation to allow a wider range of healthcare professionals — potentially including pharmacists — in the NHS to prescribe ‘low-risk’ medicines.

Changes enabled by the powers in the bill will be made using secondary legislation at a later date, and any proposed legislative changes arising from the provisions in the bill will be subject to consultation, the DHSC said.

All-Party Parliamentary Group on Access to Medicines and Medical Devices

Consultation Paper on Specials Procurement

This consultation document outlines the current system of procurement of specials in England and outlines possible scenarios for change.

It seeks written evidence from stakeholders. Please provide responses by Friday 3rd May 2019 to: emma.heywood@parliament.uk

  1. Background

For some patients and diseases there are very few suitable, safe and effective licensed medicines. Affected individuals include children, the elderly, those with life-shortening illnesses needing palliative care, those with oral and throat disease, eye disease, endocrine (hormone) problems, and especially those with skin disease. ‘Specials’ are medicines which have been specially manufactured or imported to the order of a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber for the treatment of individual patients. , Unlike licensed medicinal products, they have not been assessed by the Licensing Authority against the criteria of safety, quality and efficacy.

They are usually liquids, ointments, injections or eye drops. They are manufactured singly or in batches in the UK. In the last 10-15 years, individual pharmacies have largely stopped preparing these medicines. Instead they are produced by private manufacturers (often members of the Association of Pharmaceutical Specials Manufacturers (APSM)) or by NHS Specials Manufacturing Units (of which there are 22-23, often based in NHS Hospital Trusts and members of the NHS Pharmacy Production Committee).

  1. Problems with the procurement of specials

The following section provides a non-exhaustive list of the main issues with procurement for specials in England over the decade 2008-2018. The APPG on Access to Medicines is of the opinion that these issues will continue to present themselves unless new legislation and procedures are put in place.

  1. Price
  • Price-inflation

Attention was first drawn to this as an issue in 2008-2009. In that year the costs of specials prescribed in the community increased dramatically from £63 m. to £109 m. in one year (73%), due to an increase largely in unit price rather than in quantities prescribed. In a PCT in the North West of England in 2008-2009 there was a 122% rise in cost versus a 47% increase in quantities prescribed. Particular concerns were raised about wholesaler mark-ups and about secret ‘discounts’ or ‘professional fees’ to pharmacies from manufacturers (which do not show up in DH/PSNC discount surveys). Investigations about fraudulent practice by NHS Counter Fraud were carried out, without being able to identify prosecutable evidence, due to loopholes. Price inflation by manufacturers and wholesalers was highlighted. Direct sourcing of products from manufacturers was recommended rather than through third parties. A potential annual saving on Specials with known unit prices (a proportion of all specials) was identified as £12.7 m. or 34%, leading to a projected annual saving of £37.1 m. in 2009 if wholesalers were cut out and all specials purchased direct from the manufacturer.

  • Overly high prices

Production of medicines (‘Specials’) as one-offs or in small batches can be expensive. For example, £1,794.00 was quoted for 500g of a Dermatology Special by a community pharmacist in Wiltshire CCG in 2014 but it was possible to dispense the same item for £185 from the local hospital pharmacy. Concerns have been repeatedly raised in the media about commercial specials manufacturers (including members of the APSM) charging extremely high prices for specials which seem hard to justify (‘NHS forced to pay £1,500 for £2 pot of moisturiser. MPs demand action as Boots owner exploits loophole’. The Times 2nd February 2018; front page article[1]). Some commercial specials manufacturers (APSM members) have 2 price lists for the same items, with some items eight times the price for England versus Scotland (see Appendix for examples). Another APSM member was named in a newspaper article to have participated in fraudulent practice.[2] The British Association of Dermatologists (BAD) was provided with information that some commercial manufacturers/distributors had partnered with  community pharmacies to obtain Dundee Cream (a visible light blocker), sold by Tayside Pharmaceuticals (an NHS manufacturer) to the NHS for approximately £20, in order to sell it on for £450 in the community when prescribed for NHS patients.

  • Multiple fees

Community pharmacies in England and Wales have the right to obtain a medicine from any source they choose. Most are linked to particular wholesalers and will not obtain a non-tariff special from a far cheaper source than their usual wholesaler, as they have an incentive not to do so. The procurement system in England and Wales guarantees reimbursement of the price charged by the wholesaler for a non-tariff special- however high – plus a handling fee. Specials not listed on the Drugs Tariff Part VIIIB are dispensed at prices up to 10 times the manufacturing cost; this dispensing cost is reimbursed by the NHS in addition to a £20 handling fee.  This handling fee applies per item, for example, if it is dispensed in multiple small containers, multiple handling fees are paid for the same medicine. Items can legally be obtained by a community pharmacy from a parent or sister company, providing an incentive to seek a high price and a high profit for the parent or sister company. The Tariff-setting process that evolved from this system in England and Wales was derived from prices set by APSM members and led to very high prices in the English NHS Drugs Tariff Part VIIIB, even though the medicines could be sourced much more cheaply. A whole of market quote was not obtained. Hospital pharmacies have strict cost control and regional procurement structures and procure medicines including specials from the most cost-effective source, usually an NHS manufacturer in the case of specials.

  • Additional hidden costs

Failure to prescribe Specials has very significant costs. For example, in dermatology, the usual alternative treatments to specially prepared ointments applied by the patient are:

  1. Phototherapy (30 hospital visits) plus petrol and parking costs for the patient
  2. Immunosuppressive drugs such as ciclosporin (expensive:  £2000-4000 drug cost per patient per annum, plus 4-6 hospital appointments and numerous blood tests vaccines etc; also treatment costs for the drug side-effects of high blood pressure and kidney damage)
  3. Injected biologic drugs (£12,000-15,000 per patient per annum plus 4-6 hospital appointments plus numerous blood tests, delivery costs, treatment of side-effects such as cancer and infection etc).

Hidden costs of failure to prescribe specials occur in all specialities that require them: in palliative care, these might include uncontrolled pain or swallowing problems requiring hospital admission; in paediatrics uncontrolled abdominal pain or epilepsy requiring ambulance and hospital services; in patients with oral disease inability to eat requiring expensive parenteral nutrition; and there are many other examples of hidden costs where specials are not provided.

  • Inefficient use of NHS finance

According to OpenPrescribing, the spend on specials prescribed in the community (primary care) was £42.84 m. in 2017, but there was an easy potential saving of £23.3 m. if the 10th centile best value of price quotes had been used to source the items.[3]

Significant savings in secondary care could also be made – the spend on specials prescribed in secondary care in England in 2017 was £49.9 m.[4]

In 2013/2014 a senior NHS manufacturing pharmacist estimated the amount of money being wasted on dermatology specials: the top 12 dermatology specials dispensed in a 3-month period in England cost £845,000 but would have cost only £162,000 if obtained from an NHS manufacturing unit.

  • Other procurement systems are more cost-saving

NHS manufacturing units often produce specials identical to those produced by commercial manufacturers, at a lower cost, as they produce in larger batch sizes due to supply into Secondary Care  In Scotland, the Specials procurement system from 1st September 2015 allows dispensing without pre-authorisation if an NHS manufacturer is used. Prior to that, in Scotland, 3 quotes for non-Tariff specials including an NHS manufacturer’s quote were mandatory, and the cheapest quote of the 3 had to be used, leading to a culture of low prices for specials. This system translated into the Scottish Specials Tariff having vastly different prices to that in England. Many, but not all, of these prices are cheaper. Dermatology items are all much cheaper. If the national UK demand for specials were to be channelled to a few NHS manufacturing units, they could be batch-produced. This would make manufacturing more efficient and therefore more economic.

  1. Patient Access
  • Lack of access at primary care

Most patients requiring a special in England and Wales have been unable to obtain their medication from their GP, due to the dysfunctional primary care procurement system causing high prices, and local CCGs forbidding their GPs from prescribing them. For example, 13% of secondary care specials prescribing is on dermatology items, and 10% on ophthalmology items (compared to 2.8% and 1% respectively in primary care specials prescribing), suggesting that in the community patients are being denied their treatment if they have eye or skin problems.[5]

  • Inappropriately overburdening secondary care

Many patients have been trapped in secondary care purely to obtain a prescription for their medicine, or have been entirely denied it. In N Ireland most prescribing of medicines is in primary care, leading to many patients being denied their special by their GP and an inadequate and ineffective substitute offered. There are far fewer problems in Scotland due to the more effective procurement system.  Such prevention of prescribing is leading to deskilling of some doctors in their use and much hidden morbidity and knock-on costs. The DHSC has consistently suggested that patients denied their special should complain about their GP to NHS England and has not wished to hear about problems of patient access.

English patients in particular have become unable to obtain their treatment unless they continue to attend a hospital department for follow-up, causing pressure on outpatient appointments. Many hospital consultants have stopped prescribing Specials to patients who need them, because they are concerned that the patient will be denied treatment by their GP once they need a repeat prescription, or that the treatment will be overly costly due to the dispensing process.  In a 2013 survey by the BAD, 92% of UK consultant dermatologists used Specials; 86% of consultants had patients who had difficulty obtaining their Special in the community. A further BAD survey of UK consultants in September 2014 found that access to specials varied widely, being unlimited in Inverness; prescribed in hospital practice for a limited number of patients in Yeovil, Canterbury, Swindon and Bath but never in the community; very limited access for hospital patients in North London and non-existent in the community; no or virtually no access for patients in Norwich, Surrey, Swansea, Sheffield and Southampton. In N Ireland all prescribing was through the GP and similar access problems existed.

  1. Safety of specials
  • Lack of regulation

The use of specials in primary and secondary care has significant risks because their formulation and application has not had regulatory oversight. Specials are not tested and do not undergo clinical trials, therefore, the safety of a special cannot be guaranteed. The efficacy, quality and consistency of specials that are procured is also not controlled or regulated.

Within secondary care, NHS trusts have Unlicensed Medicines Policies which can help to control the quality assessment of unlicensed medicines, however, within primary care there is not the same level of oversight and products are often commissioned without meeting any specifications.

Even in secondary care, however, there are often products which are difficult to source and products which end up being procured are often made extemporaneously without any final product testing, and sometimes without any assurance that they will be stable and suitable for use throughout the assigned shelf-life.

Furthermore, there is a concern that patients that do receive suitable, quality safe and efficacious medicines in secondary care will not receive the same standard of medicines when they return to primary care for their supplies.

The APPG is aware that some NHS Trusts attempt to standardize the procurement of specials so that they are procured in batches across the region. Tenders focus on product quality, the shelf-life and supplying products with a Certificate of Analysis from the manufacturer.

In general, batch prepared and well controlled products tend to be cheaper to purchase than those ‘made to order’ where each time a supply is ordered the product has to be compounded specially to meet that order.

  • Aseptic service safety and costs

Aseptic pharmacy services involves the creation of medicines and treatments for patients in a sterilized environment.

The NHS relies upon commercial suppliers for at least a third of aseptic compounding. Trusts who have chosen to outsource did so for cost efficiency, investment, or capacity reasons.

NHS Improvement recently produced an interim report into ‘The Future of Pharmacy Aseptic Services in England’ and found that a majority of aseptic pharmacy facilities are near the end of their “design life”.[6] Phase two of the review is set to look at “fully costed options for a national aseptic service based on clinical networks or hubs” across sustainability and transformation partnership areas.

The interim report found significant recruitment and staff capacity difficulties issues. A lack of staff capacity is preventing c.60% Aseptic Facilities from offering desired services and, therefore, the report recommends a standard method is created to calculate capacity for national and local workforce requirements.

The report also found many points in the supply chain where waste can occur because of inconsistences and poor tracking. This wasted stock results in financial loses for Trusts.

A number of recommendations are included in the report including: ordering visibility, demand volatility, stock management, risk assessment, risk reduction, and contingency arrangements.

  1. Legislation
  • New legislation

In 2017, the Health Services Medical Supplies (Costs) Act 2017 amended the NHS Act 2006. The primary legislation was passed to provide the Government with the powers to control the spend on medicines – including specials – and prevent pharmaceutical companies from significantly overcharging on price.

The Act  had a subsection inserted in Section 1 of the Act (s.164 (8A) to (8E))[7] referring to specials, which includes pharmacy owners in the requirement to ensure that the level of remuneration for specials is reasonable. The Act also gives the Government the power to centrally procure specials or require several quotes to be sought.

Using powers delegated from the Health Services Medical Supplies (Costs) Act 2017, the Health Services Products (Disclosure and Information) Regulations 2018 were passed and came into force. As a result, the Department of Health and Social Care now receives statutory quarterly information from specials manufacturers with an NHS turnover of £5 million or more, only on items specified on the Drugs Tariff Part VIIIB (Specials). From 1.8.18, APSM members are no longer the only source of information for Tariff price determination of specials. The margin measurement system for community pharmacies in England in relation to specials has also been removed, as it was unable to estimate the profits being made on specials, and hence unfit for purpose.

  • Legislative concerns

The Act does not explicitly state that an NHS manufacturer’s quote must be included in Tariff setting for a particular item. If using an average of the price information provided through the new powers, it must be remembered that an average of a very high price (or a few very high prices) and one low price is still unnecessarily high.

The Health Services Products (Disclosure and Information) Regulations 2018 are intended to allow transparency on high profit margins on Specials, but have some key loopholes:

  • Smaller units, including most NHS Specials Production Units, are excluded from compulsorily submitting data due to their small turnover.
  • Information is not required to be submitted on non-tariff items, which, for example, includes most specials prescribed for skin disease.
  • A manufacturer may decline to produce data if this process is thought to be too onerous.
  • A manufacturer can submit data as an aggregate or estimate.

Since the Health Services Medical Supplies (Costs) Act came into force there has been no change in how specials are procured and money continues to be wasted. Although it gave the Secretary of State for Health and Social Care powers to reimburse community pharmacies differently or not at all for specials, secondary legislation has not been forthcoming.

In January 2019 the DHSC said that it was engaging informally with pharmacy and industry representatives about potential changes to the procurement and reimbursement arrangements for specials not listed with a price in the Drug Tariff.[8] However, DHSC had previously said in both July[9] and October[10] of last year that it was developing proposals and would consult relevant stakeholders before the end of 2018. Therefore, there has been a stalling of progress.

As per the Government’s statements a formal consultation is still expected.[11] However, the latest answer from DHSC (28th January[12]) makes no reference to this and instead emphasises their desire to “include more specials with a reimbursement price in the Drug Tariff” as a means to “incentivise community pharmacies to source the special at the lowest price possible”.

DHSC does acknowledge a desire to “seek alternative arrangements for specials that are not commonly prescribed and therefore cannot be listed with a reimbursement price”. Yet some stakeholders are concerned that this latest answer alludes to a desire to shift the focus onto increasing the number of drugs on the Drug Tariff rather than a complete overhaul of the reimbursement system for specials.

  1. Solutions

Very few patients receive specials in primary care; for the same annual spend, many more patients could receive treatment if the current procurement system were radically changed, to a central procurement ‘best value’ model, allowing batch production, or the Scottish model with strict price controls.

  • Increasing number of specials in the Drugs Tariff

If the Government includes more specials with a reimbursement price in the Drug Tariff then pharmacies will source these products at a controlled price.

However, this approach is limited as by their inherent nature many specials are bespoke and therefore unable to be listed. It is also not applying the powers granted to the Government via the 2017 Act, which was created in order to enable the Government to make more sweeping and cost-saving changes.

The APPG also believes that the selection of new Specials onto the Drug Tariff should happen in liaison with doctors’ specialty professional bodies, as it can’t be done through information-gathering under the new legislation (unless NHS Specials manufacturers are asked for invoices on all the Specials they dispense).

  • Central procurement

Previous dialogue in July 2018 between representatives of the APPG and the then Health Minister in charge of specials, Lord O’Shaughnessy, revealed that centrally procuring specials was the Government’s desired future approach.

Pharmacies would contact a centralised service that would procure specials on their behalf. The benefit of this system is that a centralised buyer has the advantage of a greater purchasing power so can negotiate and obtain cheaper prices than an individual pharmacy.

The exact form this system would take is unclear and therefore the specifications would have to be closely analysed if a future government proposal is created. For example, the trail of reimbursement and the place of NHS Manufacturing Units in this system would need to be detailed.

However, depending upon the details, this approach would be favourable to the APPG if it were carried out in close liaison with the body of non-profit NHS Specials Manufacturers to ensure best value, quality, transparency and batch manufacture.

  • Batch production

Coding for specials items must be unified to estimate demand. The British Association of Dermatologists (BAD) Medicines Working Group has worked hard to reduce the number of items recommended for skin disease to 39, to simplify demand and coding, and to have all items listed on the Dictionary of Medicines and Devices (DM & D). It has linked with other key specialty groups and the Royal Colleges of Physicians, Paediatrics and Child Health and Ophthalmologists to provide similar shortlists for other specialities.

By unifying prescribing, and channelling demand to a more limited number of specials, batch manufacture is facilitated. This reduces costs, while improving quality and availability.

  • Strict price control

The Government could mimic Scotland’s former method of requiring a certain amount of quotes, including an NHS one, when purchasing non-Tariff specials and for the cheapest to be used. However, the Government has previously indicated that this strict price control system is not favoured because manufacturers can still inflate quotes.

Since 2015, Scotland’s procurement system allows dispensing without pre-authorisation if an NHS manufacturer is used. Prices have been driven down since NHS manufacturing units produce specials at significantly lower prices to private suppliers. This is a result of NHS units batch-producing specials.

The APPG believes that the English procurement system would be significantly improved if it followed these processes.

  • Warning system

If there were a central reporting helpline for patients and doctors then the system could identify drug shortages and price hikes at an early stage. This would rectify some of the issues surrounding the largely unknown financial burden of certain specials on the NHS.

The APPG envisages this working alongside a new procurement system.

  1. Consultation Questions

1. 

Q. In what capacity are you responding to this consultation?

Q. Please briefly outline your experiences with the consumption, procurement, delivery or system design of specials.

Q. Has all the relevant evidence for this consultation document been taken into account? If ‘No’, please give details.

2.

Q. Please comment on the medical specialisms and disease areas that you are aware are affected most by the procurement of specials.

Q. Do you agree with the consultation document’s findings regarding price-inflation, multiple fees and additional hidden costs for specials in England?

Q. Do you believe a saving could be made to NHS England if a new procurement system were put in place?

Q. Do you agree with the statement that the current procurement of specials in England impacts patient access to medicines in primary care?

Q. What do you consider to be the major impacts of patients requiring secondary care services to obtain a prescription for their special medicine?

Q. Please provide any other comments you may have on the current system of procurement for specials in England.

3.

Q. Do you believe that there is an issue with regards to the safety of specials in England within (i) primary care and (ii) secondary care?

Q. What mechanisms do you think should be in place to ensure the safety, efficacy, quality and consistency of specials?

Q. Do you believe aseptic compounding pharmacies have a capacity issue and, if yes, what steps should be taken to relieve these capacity constraints?

Q. Is batch testing a viable solution to improve patient safety for specials?

4.

Q. Can you explain whether existing legislation ensures that the level of remuneration for specials is reasonable?

Q. Does the Health Services Medical Supplies (Costs) Act provide the necessary powers to alter the procurement practices for specials in a satisfactory manner?

Q. Do you believe that The Health Services Products (Disclosure and Information) Regulations 2018 have adequately improved the provision of information on the pricing of specials.

5.

Q. Please provide any comments that you may have about the potential merits and limitations of the solutions outlined in this document:

a. Increasing number of specials in the Drugs Tariff

b. Central procurement

c. Batch production

d. Strict price control

e. Warning system

Q. Are there any changes, additions or new procurement systems that you would like to propose?

Q. If you support a new procurement system, which do you favour and why?

Q. Please provide any additional comments on the consultation document.

 

Appendix:

Special Scottish Tariff Feb 2019 English Tariff Feb 2019

 

Price available from the cheapest commercial manufacturer  Price available from NHS

Manufacturer

Coal tar 5% in yellow soft paraffin 100g £29.68 £113.67 £29.68 £29.68
Ichthammol 1%/ Zinc Oxide 15% in yellow soft paraffin 200g £31.24 £293.55 £31.24 £31.24
Salicylic Acid 2% in aqueous cream 100g £37.64 £53.37 £37.64 £37.64
Salicylic Acid 5% in aqueous cream 100g £37.64 £68.04 £37.64 £37.64
Salicylic Acid 10% in aqueous cream 100g £37.64 £57.75 £37.64 £37.64
Eosin Solution 2% 100ml £31.03 £113.76 £31.03 £31.03

 


[3] Data from Richard Croker/ Ben Goldacre 2018 (OpenPrescribing, Oxford)

[4] Data from PresQUIPP 2018

[5] Estimate using DGH data from RUH Bath 2018

UK medicines access under threat?

Pharma Times, Selina McKee, May 2017 issue

 

According to an ABPI survey of its member companies, 71% of respondents said the new system for drug approval by the National Institute for Health & Care Excellence (NICE) would see their companies prioritising the launch of new medicines in European countries, rather than in the UK. Data already points to the UK’s underperformance on the uptake of new medicines; the updated system is set to fuel further deterioration rather than improving the UK’s performance.

 

Falsified Medicines Directive: opportunity or obstacle?

The Pharmaceutical Journal, Daloni Carlisle, 25 April 2017

 

The implementation of the Falsified Medicines Directive has been confirmed despite the Brexit vote last month. Jerome Bertin, Managing Director of SecurMed, explained that the MHRA had been given ministerial guidance to continue the implementation of the European Directive with the deadline of February 2019. The general view is that the medicines supply chain is becoming global and all countries, even outside the European Union, are adopting similar practices. On the other hand, leaving the European Union will offer the unique opportunity for the UK to adopt the Directive to its specific needs.

 

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

Falsified Medicines Directive: opportunity or obstacle?

The Pharmaceutical Journal, Daloni Carlisle, 25 April 2017

 

Details surrounding the UK’s implementation of the Falsified Medicines Directive (FMD) have been clouded by the prospect of Brexit. It is now clear that the FMD will go ahead, but there are mixed views as to whether or not it will offer an efficient way to secure the medicines supply chain.

The past decade has seen some lurid headlines about falsified medicines in European countries. Fake Valium (diazepam) has been implicated in several deaths in Scotland; stolen vials of the breast cancer drug Herceptin (trastuzumab) were potentially tampered with and reintroduced to the supply chain in Italy; there have been ongoing reports of fake Viagra (sildenafil); and batches of fake Lipitor (atorvastatin) were discovered in the legitimate supply chain in the UK.

The EU’s system-wide response to the threat of counterfeit medicines entering the formal supply chain — as distinct from the threat of drugs procured via the internet or on the street — is the Falsified Medicines Directive (FMD).

The FMD aims to provide a secure supply chain from manufacturers through wholesale and pre-wholesale to dispensers and, finally, patients. It’s been in the pipeline since 2013, when it became European law, and will go live in pharmacies by 9 February 2019. However, since the FMD is European legislation and the UK is now firmly on course to leave the EU, why is the UK continuing down the FMD path?

“The elephant in the room is Brexit,” says Jerome Bertin, managing director of SecurMed, a not-for-profit organisation that has responsibility for delivering the UK’s medicines verification system, a core requirement of the FMD (see Box).

“The Medicines and Healthcare products Regulatory Agency [MHRA, which regulates medicines and medical devices in the UK] has been given guidance by ministers that… the UK will be in the EU for the next two years, during which time [the UK] will apply all safety of medicine regulations. They want it to continue.

“Whatever happens and whatever the outcome of [Brexit] negotiations, [the UK] will remain full participants [of the FMD].”

The general view is that this is as it should be. For a start, an end-to-end secure medicines supply chain approach is now becoming global. Countries such as China, India and South Korea are all adopting the same system and the UK needs to remain part of that global market. One strong argument against opting out of the FMD is that it would make the UK a magnet for counterfeit drugs from all over the world.

However, by leaving the EU, the UK may be able to adapt the FMD to suit the unique needs of the NHS.

Aileen Bryson, interim director of the Royal Pharmaceutical Society (RPS) in Scotland, says: “We may be able to develop compromises — but that is at the end of a very long to-do list. It may well be revisited in future years.”

Aileen Bryson, interim director of the Royal Pharmaceutical Society in Scotland, says the UK may be able to develop compromises when implementing the FMD

Just short of two years ahead of full implementation, there are more unknowns than knowns and precious little in the way of infrastructure.

 

Immediate steps

The MHRA has UK-wide responsibility for working out how best to put the FMD into UK law and is working on the matter through an implementation advisory board and a series of task and finish groups.

One starting point is the National Medicines Verification System (NMVS), a national data repository that will be connected to a central European hub (the European Medicines Verification System, EMVS). In the UK, delivery of the NMVS is the responsibility of SecurMed, which represents supply chain stakeholder associations, such as the Association of the British Pharmaceutical Industry, the British Association of European Pharmaceutical Distributors, the British Generics Manufacturers Association, the Company Chemists’ Association, the Healthcare Distribution Association (HDA) and the National Pharmacy Association (NPA).

The immediate task for SecurMed is to commission a software provider to build the NMVS. It will choose one of three companies listed as preferred providers by the European Medicines Verification Organisation (EMVO), which has responsibility for the formation of the EMVS — Aegate Holdings Limited, Arvato Systems GmbH and Solidsoft Reply.

“We are using the national blueprint model developed by EMVO,” says Bertin. EMVO has identified the three providers as having the capability and capacity to build national medicines verification systems for 28 EU member states and non-EU countries such as Switzerland and Norway that have elected to join the FMD — and to do so cost effectively.

The UK will remain full participants of the FMD, says Jerome Bertin, managing director of SecurMed, a not-for-profit organisation that has responsibility for delivering the UK’s medicines verification system

An announcement about the final selection for the UK’s NMVS provider is expected imminently. “[The] SecurMed UK board has identified the preferred blueprint service provider and we are in the final stages of contract negotiation,” says Bertin. “We need to set up the system and bring on board all the different players along the supply chain ready for February 2019 when we are all obliged to comply with the FMD by law.”

And by ‘all’ he means around 15,000 community pharmacies, 11,000 dispensing doctors, 450 hospital pharmacies, 2,200 wholesale licence holders and 50–60 software suppliers.

This doesn’t include the other small-scale dispensers of medicines referred to in article 23 of the FMD, including vets, opticians, dentists, oil-rig clinics, universities, fishing trawlers, mountain rescue teams, paramedics and emergency medicine practitioners aboard ambulances, nursing and residential homes and prisons. Currently, the proposal is that wholesalers should decommission medicines on their behalf; the MHRA expects to issue a three-month public consultation on ‘article 23 exemptions’ in 2017.

 

Added benefits; potential problems

Once the NMVS is in place — or at least once some technical specifications are made available — pharmacy software system suppliers will need to build their interfaces to the national system. Pharmacies will need to invest in scanners and start to understand how workflows will change. New standard operating procedures will need to be written. There will be training requirements, as well as a need to understand how compliance with the FMD will be regulated.

And this is where the known unknowns come in.

Gareth Jones, head of public affairs for the NPA, a trade association representing the owners of independent pharmacies, is involved in the various European and national working groups now teasing out the detail of implementing the FMD.

Gareth Jones, head of public affairs for the National Pharmacy Association, identifies opportunities around improved medicines supply, recall and stock control

He says, with what may be typically English understatement: “The wording of the legislation is challenging” and that the working groups are looking carefully at what it means.

“There are certainly opportunities but people are very much focused on the burden,” he adds. “We need to maximise the upside.”

Jones says there are three potential added benefits of implementing the FMD. With each medicine barcoded, there is an opportunity to improve supply errors, for example through electronic checking of expiry dates.

There is also the scope to build in medicine recall into whatever systems deployed at dispensing level to communicate with the NMVS. “There are systems in place already,” he says. “But this could be an extra level.” Finally, systems could support better stock control.

Shanel Raichura, a community pharmacist and director of pharmacy at healthcare software company EMIS Health, says these functions should be built into IT systems — but whether that will be possible in the short term is not clear.

“We want to achieve so much more than simply decommissioning the products. We believe we can provide businesses with better stock control and significantly increase the spotlight on improving dispensing errors. It fits nicely with the quality payment scheme [introduced as part of the new community pharmacy funding settlement for England for 2017–2018],” he says. But would it be version 1 or version 2 of any new system? It’s not clear.

Jones’ list of disadvantages is longer than his list of advantages — this is a system originating from Europe that may not take account of UK anomalies, he explains. In Europe, for example, medicine packs are generally not split. But in the UK, packs are often opened and strips of tablets are shared between patients. Such practice does not sit easily with a system where a pack must be scanned and dispensed to a patient — if a box has been scanned once and the code decommissioned, a second scan for a second patient will trigger an alert.

For similar reasons, it is not clear how the FMD will work when community pharmacists prepare a seven-day supply of multiple medications for patients with co-morbidities.

Under the ten-day rule — a hard-won concession by the RPS — a pharmacist may keep a decommissioned medicine on the shelf for up to ten days. It can be un-decommissioned by scanning it back into the system, but only within the ten-day limit.

As Bryson explains: “[The RPS] fought hard for this at European level. Originally, the EU wanted a 48-hour rule but we felt that would be completely unworkable in the UK.”

Even so, working through the implications of the ten-day rule in high street pharmacy is going to be taxing. What about the patient who orders their asthma inhaler three weeks in advance — and then does not pick it up for a fortnight?

“We fear that there will be an increase in medicines waste,” says Jones. “It all depends on how new processes work in practice and how we develop workarounds.”

One option, says Bertin, might be to verify medicines as they are bagged and create a label with an IT-system-generated code that triggers decommissioning for all contents at the time the medicines are handed to the patient.

Another hurdle, according to Jones, is that the ‘hub and spoke’ model of dispensing — whereby prescriptions are assembled at a central hub and then shipped to pharmacies where they are dispensed to the patient — is incompatible with the FMD and the ten-day rule.

If the situation in community pharmacy is complex, then the situation in hospital pharmacy is even more so. As the MHRA points out, the two sectors will handle the FMD quite differently: “The obligations on pharmacies and hospitals (considered as healthcare institutions) vary under the delegated regulation. Healthcare institutions are able to decommission medicinal products at any point once they receive them, pharmacies must decommission items at the point of supply.”

Tim Root, specialist pharmacist at the NHS Specialist Pharmacy Service, an advice service that supports medicines optimisation across the NHS, and strategic lead for medicines at the NHS London Procurement Partnership, a membership organisation set up to enhance the purchasing power of NHS organisations, offers his perspective on what is worrying the sector.

Tim Root, specialist pharmacist at the NHS Specialist Pharmacy Service, says the complexity of the internal NHS supply chain will make the principle of decommissioining close to the patient difficult in hospitals

“The proposal for NHS secondary care remains the principle of FMD: decommission as close to the patient as possible. But there are so many ifs and buts generated by the complexity of the internal NHS supply chain that as soon as you start to look at this, you are forced to retreat from that quite quickly,” he says.

One simple example is ward stock, Root explains. “Despite everyone’s best efforts, wards may sometimes accumulate excess stock which needs to be sent back to the pharmacy to avoid waste and release storage space. What happens if that medicine has been decommissioned weeks earlier?”

Nevertheless, “decommission close to the patient” remains the proposal. As Root points out: “The flexibilities allowed are still relatively few. [The problem of] squaring the theoretical proposal with the reality of the NHS is very, very real.”

Input from the innovators

The people who are best equipped to come up with solutions to these potential problems — pharmacists and innovators — are worried that they are not being involved. They fear that history will repeat itself, and that lessons won’t have been learnt from the introduction of other technologies, such as the electronic prescription service.

Sanjay Ganvir, chair of Camden and Islington local pharmaceutical committee and superintendent pharmacist at Green Light Pharmacy in London, explains: “ETP [the electronic transmission of prescriptions] sounded like a great idea — and it was. But… it could have run a lot smoother. The IT did not work as well as it could have and it resulted in a lot more work for pharmacists. My concern is that this [FMD] will be the same.”

Sanjay Ganvir, chair of Camden and Islington local pharmaceutical committee and superintendent pharmacist at Green Light Pharmacy in London, fears that the FMD could result in a lot more work for pharmacists

Ganvir acknowledges the MHRA’s committees and task and finish groups, but says the innovators are not on them. “Who is going to make this happen,” he asks. “It’s the innovators at the coalface and the jobbing community pharmacists who understand the processes and, as far as I can see, they are not involved in the design of the new processes that are going to be needed.”

Raichura talks about the creation of interfaces between IT systems and the NMVS as being an “operational nightmare”.

“FMD will absolutely change the operational landscape in the pharmacy,” he says. “For me, as a practising pharmacist and also working for EMIS, I want to make sure the process is as streamlined as possible.”

Raichura does not expect EMIS customers to jump from one system to another so the intention is to provide “seamless integration” across the patient medication record (PMR) system, the system used to decommission packs and other processes such as the electronic transmission of prescriptions. But he is not sure it can work. “The model as proposed is not feasible with current processes,” he says. Nor is he convinced the timetable is achievable. “We have a significant development road map and at the moment very little information.”

Bertin suggests that “end user pharmacy organisations” can get involved via their industry associations and directs them to a website — http://www.fmdsource.co.uk— set up by the UK FMD working group for community pharmacy, which includes representatives of all the main bodies in community pharmacy. The site contains information to help UK pharmacies prepare for whatever new authentication system is developed and is tailored to reflect the way UK pharmacies operate.

In terms of system development, Bertin says SecurMed will engage with pharmacy system suppliers. “It will be the PMR solution providers who will provide the pharmacy end user FMD solutions including technology, setup and operational support,” he says.

Jones’ list of challenges still stands, however. He wants to know what happens if broadband connections go down, for example, or what happens if a product fails to authenticate not because of counterfeit issues but because of barcode errors?

Then there is the cost of verification: manufacturers will bear the cost of the European and national databases but there could also be substantial costs to pharmacy, says Jones.

“The pharmacy contract says that any regulatory burden must be covered by the NHS and we will be making a strong case for the costs of implementation to be met by the NHS,” he says. “It is not insignificant. There is the cost of scanners, staff time, training, and procedures will need to change. We handle billions of packs [of medicines] a year and so while it may be true it takes two seconds to scan one pack, multiply that by billions and you have a big number.”

And last, but certainly not least, there is the matter of regulation. Who is going to be in charge of making sure pharmacists comply? What happens if they don’t? The MHRA says that this is an area where the UK can apply some flexibility to the FMD — the UK can develop its own rules. But these rules will need to be incorporated into UK law. A consultation is expected in 2017.

All change

For all this concern, some people are optimistic that the FMD is achievable and will deliver safety benefits.

Among them is Roger Nichols, head of pharmacy operations at Boots UK and the representative of the Company Chemists’ Association at SecurMed, who says that work to understand the changes that need to be made will get under way soon.

“I am sure that, as with any initiative of this type, there will be some unforeseen eventualities. There are some unknowns, but that being said, there is every reason we will be able to contract with a blueprint service provider, establish a verification system and that all actors in the supply chain will be able to undertake verification.”

Others say the timetable is not as tight as it looks. The FMD applies only to medicines manufactured after the 9 February 2019 implementation date and these won’t be in hospital or community pharmacy for quite some time. As Bryson says, “it will take years to get the system up and running”.

There is a long way to go before anyone has a clear idea of what FMD in practice will look and feel like. There’s a mountain of work to do and a deadline by which to do it. The only certainty is this: pharmacy processes are about to change — again.

 

How medicines verification will work in practice

The Falsified Medicines Directive will result in “a bookend system”, according to Jonathan Buisson, international pharmacy and policy manager at Walgreens Boots Alliance, parent company of Boots, the largest community pharmacy chain in the UK.

The Falsified Medicines Directive will result in “a bookend system”, according to Jonathan Buisson, international pharmacy and policy manager at Walgreens Boots Alliance

“Manufacturers will give all their packs unique serial numbers and packs will carry a code that includes what the product is, the serial number, batch and expiry data. Depending on the market, there may also be a reimbursement number, although this is not relevant in the UK. This will all be encoded in a 2D barcode or matrix printed on each pack,” he explains.

Manufacturers will upload this pack data to the European Medicines Verification System (EMVS), a central information hub and data router. As medicines are shipped to their point of sale, such as the UK, data from the EMVS will be transferred to the UK’s National Medicines Verification System (NMVS).

The FMD applies to prescription-only medicines as well as some over-the-counter medicines where there is a track record of counterfeiting. The package will be tracked from manufacturer through to the pharmacy, where it will be dispensed to the patient.

“The pharmacist will scan the code on the pack and send the data to the NMVS,” Buisson continues. “In the vast majority of cases, this should return a message saying that the code matches one uploaded by a manufacturer and the pack is genuine. The pharmacist will then decommission the pack — changing its status in the system to ‘inactive’ — before handing the medicine to the patient.

“However, if the message comes back negative, there should be a reason for this, such as [the pack] has been recalled, withdrawn or dispensed elsewhere, and the pharmacist will have to take appropriate action. We do not know yet how often the system will respond like this, but we assume it will be rare.”

Alongside the barcode check will be a visual check of anti-tamper measures that will be included in packaging of medicines covered by the directive.

UK medicines access under threat?

Pharma Times, Selina McKee, May 2017 issue

 

According to an ABPI survey of its member companies, 71% of respondents said the new system for drug approval by the National Institute for Health & Care Excellence (NICE) would see their companies prioritising the launch of new medicines in European countries, rather than in the UK. Data already points to the UK’s underperformance on the uptake of new medicines; the updated system is set to fuel further deterioration rather than improving the UK’s performance.

 

Falsified Medicines Directive: opportunity or obstacle?

The Pharmaceutical Journal, Daloni Carlisle, 25 April 2017

 

The implementation of the Falsified Medicines Directive has been confirmed despite the Brexit vote last month. Jerome Bertin, Managing Director of SecurMed, explained that the MHRA had been given ministerial guidance to continue the implementation of the European Directive with the deadline of February 2019. The general view is that the medicines supply chain is becoming global and all countries, even outside the European Union, are adopting similar practices. On the other hand, leaving the European Union will offer the unique opportunity for the UK to adopt the Directive to its specific needs.

 

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

Falsified Medicines Directive: opportunity or obstacle?

The Pharmaceutical Journal, Daloni Carlisle, 25 April 2017

 

Details surrounding the UK’s implementation of the Falsified Medicines Directive (FMD) have been clouded by the prospect of Brexit. It is now clear that the FMD will go ahead, but there are mixed views as to whether or not it will offer an efficient way to secure the medicines supply chain.

The past decade has seen some lurid headlines about falsified medicines in European countries. Fake Valium (diazepam) has been implicated in several deaths in Scotland; stolen vials of the breast cancer drug Herceptin (trastuzumab) were potentially tampered with and reintroduced to the supply chain in Italy; there have been ongoing reports of fake Viagra (sildenafil); and batches of fake Lipitor (atorvastatin) were discovered in the legitimate supply chain in the UK.

The EU’s system-wide response to the threat of counterfeit medicines entering the formal supply chain — as distinct from the threat of drugs procured via the internet or on the street — is the Falsified Medicines Directive (FMD).

The FMD aims to provide a secure supply chain from manufacturers through wholesale and pre-wholesale to dispensers and, finally, patients. It’s been in the pipeline since 2013, when it became European law, and will go live in pharmacies by 9 February 2019. However, since the FMD is European legislation and the UK is now firmly on course to leave the EU, why is the UK continuing down the FMD path?

“The elephant in the room is Brexit,” says Jerome Bertin, managing director of SecurMed, a not-for-profit organisation that has responsibility for delivering the UK’s medicines verification system, a core requirement of the FMD (see Box).

“The Medicines and Healthcare products Regulatory Agency [MHRA, which regulates medicines and medical devices in the UK] has been given guidance by ministers that… the UK will be in the EU for the next two years, during which time [the UK] will apply all safety of medicine regulations. They want it to continue.

“Whatever happens and whatever the outcome of [Brexit] negotiations, [the UK] will remain full participants [of the FMD].”

The general view is that this is as it should be. For a start, an end-to-end secure medicines supply chain approach is now becoming global. Countries such as China, India and South Korea are all adopting the same system and the UK needs to remain part of that global market. One strong argument against opting out of the FMD is that it would make the UK a magnet for counterfeit drugs from all over the world.

However, by leaving the EU, the UK may be able to adapt the FMD to suit the unique needs of the NHS.

Aileen Bryson, interim director of the Royal Pharmaceutical Society (RPS) in Scotland, says: “We may be able to develop compromises — but that is at the end of a very long to-do list. It may well be revisited in future years.”

Aileen Bryson, interim director of the Royal Pharmaceutical Society in Scotland, says the UK may be able to develop compromises when implementing the FMD

Just short of two years ahead of full implementation, there are more unknowns than knowns and precious little in the way of infrastructure.

 

Immediate steps

The MHRA has UK-wide responsibility for working out how best to put the FMD into UK law and is working on the matter through an implementation advisory board and a series of task and finish groups.

One starting point is the National Medicines Verification System (NMVS), a national data repository that will be connected to a central European hub (the European Medicines Verification System, EMVS). In the UK, delivery of the NMVS is the responsibility of SecurMed, which represents supply chain stakeholder associations, such as the Association of the British Pharmaceutical Industry, the British Association of European Pharmaceutical Distributors, the British Generics Manufacturers Association, the Company Chemists’ Association, the Healthcare Distribution Association (HDA) and the National Pharmacy Association (NPA).

The immediate task for SecurMed is to commission a software provider to build the NMVS. It will choose one of three companies listed as preferred providers by the European Medicines Verification Organisation (EMVO), which has responsibility for the formation of the EMVS — Aegate Holdings Limited, Arvato Systems GmbH and Solidsoft Reply.

“We are using the national blueprint model developed by EMVO,” says Bertin. EMVO has identified the three providers as having the capability and capacity to build national medicines verification systems for 28 EU member states and non-EU countries such as Switzerland and Norway that have elected to join the FMD — and to do so cost effectively.

The UK will remain full participants of the FMD, says Jerome Bertin, managing director of SecurMed, a not-for-profit organisation that has responsibility for delivering the UK’s medicines verification system

An announcement about the final selection for the UK’s NMVS provider is expected imminently. “[The] SecurMed UK board has identified the preferred blueprint service provider and we are in the final stages of contract negotiation,” says Bertin. “We need to set up the system and bring on board all the different players along the supply chain ready for February 2019 when we are all obliged to comply with the FMD by law.”

And by ‘all’ he means around 15,000 community pharmacies, 11,000 dispensing doctors, 450 hospital pharmacies, 2,200 wholesale licence holders and 50–60 software suppliers.

This doesn’t include the other small-scale dispensers of medicines referred to in article 23 of the FMD, including vets, opticians, dentists, oil-rig clinics, universities, fishing trawlers, mountain rescue teams, paramedics and emergency medicine practitioners aboard ambulances, nursing and residential homes and prisons. Currently, the proposal is that wholesalers should decommission medicines on their behalf; the MHRA expects to issue a three-month public consultation on ‘article 23 exemptions’ in 2017.

 

Added benefits; potential problems

Once the NMVS is in place — or at least once some technical specifications are made available — pharmacy software system suppliers will need to build their interfaces to the national system. Pharmacies will need to invest in scanners and start to understand how workflows will change. New standard operating procedures will need to be written. There will be training requirements, as well as a need to understand how compliance with the FMD will be regulated.

And this is where the known unknowns come in.

Gareth Jones, head of public affairs for the NPA, a trade association representing the owners of independent pharmacies, is involved in the various European and national working groups now teasing out the detail of implementing the FMD.

Gareth Jones, head of public affairs for the National Pharmacy Association, identifies opportunities around improved medicines supply, recall and stock control

He says, with what may be typically English understatement: “The wording of the legislation is challenging” and that the working groups are looking carefully at what it means.

“There are certainly opportunities but people are very much focused on the burden,” he adds. “We need to maximise the upside.”

Jones says there are three potential added benefits of implementing the FMD. With each medicine barcoded, there is an opportunity to improve supply errors, for example through electronic checking of expiry dates.

There is also the scope to build in medicine recall into whatever systems deployed at dispensing level to communicate with the NMVS. “There are systems in place already,” he says. “But this could be an extra level.” Finally, systems could support better stock control.

Shanel Raichura, a community pharmacist and director of pharmacy at healthcare software company EMIS Health, says these functions should be built into IT systems — but whether that will be possible in the short term is not clear.

“We want to achieve so much more than simply decommissioning the products. We believe we can provide businesses with better stock control and significantly increase the spotlight on improving dispensing errors. It fits nicely with the quality payment scheme [introduced as part of the new community pharmacy funding settlement for England for 2017–2018],” he says. But would it be version 1 or version 2 of any new system? It’s not clear.

Jones’ list of disadvantages is longer than his list of advantages — this is a system originating from Europe that may not take account of UK anomalies, he explains. In Europe, for example, medicine packs are generally not split. But in the UK, packs are often opened and strips of tablets are shared between patients. Such practice does not sit easily with a system where a pack must be scanned and dispensed to a patient — if a box has been scanned once and the code decommissioned, a second scan for a second patient will trigger an alert.

For similar reasons, it is not clear how the FMD will work when community pharmacists prepare a seven-day supply of multiple medications for patients with co-morbidities.

Under the ten-day rule — a hard-won concession by the RPS — a pharmacist may keep a decommissioned medicine on the shelf for up to ten days. It can be un-decommissioned by scanning it back into the system, but only within the ten-day limit.

As Bryson explains: “[The RPS] fought hard for this at European level. Originally, the EU wanted a 48-hour rule but we felt that would be completely unworkable in the UK.”

Even so, working through the implications of the ten-day rule in high street pharmacy is going to be taxing. What about the patient who orders their asthma inhaler three weeks in advance — and then does not pick it up for a fortnight?

“We fear that there will be an increase in medicines waste,” says Jones. “It all depends on how new processes work in practice and how we develop workarounds.”

One option, says Bertin, might be to verify medicines as they are bagged and create a label with an IT-system-generated code that triggers decommissioning for all contents at the time the medicines are handed to the patient.

Another hurdle, according to Jones, is that the ‘hub and spoke’ model of dispensing — whereby prescriptions are assembled at a central hub and then shipped to pharmacies where they are dispensed to the patient — is incompatible with the FMD and the ten-day rule.

If the situation in community pharmacy is complex, then the situation in hospital pharmacy is even more so. As the MHRA points out, the two sectors will handle the FMD quite differently: “The obligations on pharmacies and hospitals (considered as healthcare institutions) vary under the delegated regulation. Healthcare institutions are able to decommission medicinal products at any point once they receive them, pharmacies must decommission items at the point of supply.”

Tim Root, specialist pharmacist at the NHS Specialist Pharmacy Service, an advice service that supports medicines optimisation across the NHS, and strategic lead for medicines at the NHS London Procurement Partnership, a membership organisation set up to enhance the purchasing power of NHS organisations, offers his perspective on what is worrying the sector.

Tim Root, specialist pharmacist at the NHS Specialist Pharmacy Service, says the complexity of the internal NHS supply chain will make the principle of decommissioining close to the patient difficult in hospitals

“The proposal for NHS secondary care remains the principle of FMD: decommission as close to the patient as possible. But there are so many ifs and buts generated by the complexity of the internal NHS supply chain that as soon as you start to look at this, you are forced to retreat from that quite quickly,” he says.

One simple example is ward stock, Root explains. “Despite everyone’s best efforts, wards may sometimes accumulate excess stock which needs to be sent back to the pharmacy to avoid waste and release storage space. What happens if that medicine has been decommissioned weeks earlier?”

Nevertheless, “decommission close to the patient” remains the proposal. As Root points out: “The flexibilities allowed are still relatively few. [The problem of] squaring the theoretical proposal with the reality of the NHS is very, very real.”

Input from the innovators

The people who are best equipped to come up with solutions to these potential problems — pharmacists and innovators — are worried that they are not being involved. They fear that history will repeat itself, and that lessons won’t have been learnt from the introduction of other technologies, such as the electronic prescription service.

Sanjay Ganvir, chair of Camden and Islington local pharmaceutical committee and superintendent pharmacist at Green Light Pharmacy in London, explains: “ETP [the electronic transmission of prescriptions] sounded like a great idea — and it was. But… it could have run a lot smoother. The IT did not work as well as it could have and it resulted in a lot more work for pharmacists. My concern is that this [FMD] will be the same.”

Sanjay Ganvir, chair of Camden and Islington local pharmaceutical committee and superintendent pharmacist at Green Light Pharmacy in London, fears that the FMD could result in a lot more work for pharmacists

Ganvir acknowledges the MHRA’s committees and task and finish groups, but says the innovators are not on them. “Who is going to make this happen,” he asks. “It’s the innovators at the coalface and the jobbing community pharmacists who understand the processes and, as far as I can see, they are not involved in the design of the new processes that are going to be needed.”

Raichura talks about the creation of interfaces between IT systems and the NMVS as being an “operational nightmare”.

“FMD will absolutely change the operational landscape in the pharmacy,” he says. “For me, as a practising pharmacist and also working for EMIS, I want to make sure the process is as streamlined as possible.”

Raichura does not expect EMIS customers to jump from one system to another so the intention is to provide “seamless integration” across the patient medication record (PMR) system, the system used to decommission packs and other processes such as the electronic transmission of prescriptions. But he is not sure it can work. “The model as proposed is not feasible with current processes,” he says. Nor is he convinced the timetable is achievable. “We have a significant development road map and at the moment very little information.”

Bertin suggests that “end user pharmacy organisations” can get involved via their industry associations and directs them to a website — http://www.fmdsource.co.uk— set up by the UK FMD working group for community pharmacy, which includes representatives of all the main bodies in community pharmacy. The site contains information to help UK pharmacies prepare for whatever new authentication system is developed and is tailored to reflect the way UK pharmacies operate.

In terms of system development, Bertin says SecurMed will engage with pharmacy system suppliers. “It will be the PMR solution providers who will provide the pharmacy end user FMD solutions including technology, setup and operational support,” he says.

Jones’ list of challenges still stands, however. He wants to know what happens if broadband connections go down, for example, or what happens if a product fails to authenticate not because of counterfeit issues but because of barcode errors?

Then there is the cost of verification: manufacturers will bear the cost of the European and national databases but there could also be substantial costs to pharmacy, says Jones.

“The pharmacy contract says that any regulatory burden must be covered by the NHS and we will be making a strong case for the costs of implementation to be met by the NHS,” he says. “It is not insignificant. There is the cost of scanners, staff time, training, and procedures will need to change. We handle billions of packs [of medicines] a year and so while it may be true it takes two seconds to scan one pack, multiply that by billions and you have a big number.”

And last, but certainly not least, there is the matter of regulation. Who is going to be in charge of making sure pharmacists comply? What happens if they don’t? The MHRA says that this is an area where the UK can apply some flexibility to the FMD — the UK can develop its own rules. But these rules will need to be incorporated into UK law. A consultation is expected in 2017.

All change

For all this concern, some people are optimistic that the FMD is achievable and will deliver safety benefits.

Among them is Roger Nichols, head of pharmacy operations at Boots UK and the representative of the Company Chemists’ Association at SecurMed, who says that work to understand the changes that need to be made will get under way soon.

“I am sure that, as with any initiative of this type, there will be some unforeseen eventualities. There are some unknowns, but that being said, there is every reason we will be able to contract with a blueprint service provider, establish a verification system and that all actors in the supply chain will be able to undertake verification.”

Others say the timetable is not as tight as it looks. The FMD applies only to medicines manufactured after the 9 February 2019 implementation date and these won’t be in hospital or community pharmacy for quite some time. As Bryson says, “it will take years to get the system up and running”.

There is a long way to go before anyone has a clear idea of what FMD in practice will look and feel like. There’s a mountain of work to do and a deadline by which to do it. The only certainty is this: pharmacy processes are about to change — again.

 

How medicines verification will work in practice

The Falsified Medicines Directive will result in “a bookend system”, according to Jonathan Buisson, international pharmacy and policy manager at Walgreens Boots Alliance, parent company of Boots, the largest community pharmacy chain in the UK.

The Falsified Medicines Directive will result in “a bookend system”, according to Jonathan Buisson, international pharmacy and policy manager at Walgreens Boots Alliance

“Manufacturers will give all their packs unique serial numbers and packs will carry a code that includes what the product is, the serial number, batch and expiry data. Depending on the market, there may also be a reimbursement number, although this is not relevant in the UK. This will all be encoded in a 2D barcode or matrix printed on each pack,” he explains.

Manufacturers will upload this pack data to the European Medicines Verification System (EMVS), a central information hub and data router. As medicines are shipped to their point of sale, such as the UK, data from the EMVS will be transferred to the UK’s National Medicines Verification System (NMVS).

The FMD applies to prescription-only medicines as well as some over-the-counter medicines where there is a track record of counterfeiting. The package will be tracked from manufacturer through to the pharmacy, where it will be dispensed to the patient.

“The pharmacist will scan the code on the pack and send the data to the NMVS,” Buisson continues. “In the vast majority of cases, this should return a message saying that the code matches one uploaded by a manufacturer and the pack is genuine. The pharmacist will then decommission the pack — changing its status in the system to ‘inactive’ — before handing the medicine to the patient.

“However, if the message comes back negative, there should be a reason for this, such as [the pack] has been recalled, withdrawn or dispensed elsewhere, and the pharmacist will have to take appropriate action. We do not know yet how often the system will respond like this, but we assume it will be rare.”

Alongside the barcode check will be a visual check of anti-tamper measures that will be included in packaging of medicines covered by the directive.

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

See the Infographic

Apply to become a Member

Membership of the HDA guarantees your organisation:

  • Access to leading policy and industry forums of debate and discussion
  • Invitations to a range of networking industry events organised through the year, including an Annual Conference and a Business Day
  • Representation on HDA working parties, including the Members’ Liaison Group
  • A daily Political and Media Bulletin and HDA Newsletters
  • Access to HDA policy documents and all sections of the HDA website
  • Branding and marketing opportunities
Apply Now

Already a Member?