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HDA Media And Political Bulletin – 05 May 2016

Revealed: Funding plans could increase multiples’ dominance

28 April 2016, Chemist & Druggist, Beth Kennedy

 

The Pharmaceutical Services Negotiating Committee (PSNC) has published The Department of Health’s (DH) source papers that informed initial discussions about cuts. The papers show the DH recognises that large chains may dominate the sector after the cuts, but thinks that the current model of pharmacy funding encourages clustering and does not offer incentives to provide a quality service.

 

The documents were also analysed by the Good Health Suite.

 

Chemist and Druggist also reports that London pharmacies may be hit by the funding cuts the hardest, according to Pharmacy London.

 

2016-04 Item-Level Only? A Closer Look at the Real EU-FMD Requirements

5 May 2016, Packaging Europe, Christoph Krähenbühl

 

Packaging Europe challenges the assumption that the European Falsified Medicines Directive (FMD) will be felt primarily by the pharmaceutical manufacturers and pharmacists, suggesting that it will also have a major impact on wholesalers and distributors. The article bases this claim off Chapter V of the DR which states that wholesalers must verify authenticity of products in their ‘physical possession’.

 

HDA welcomes PSNC proposals for enhanced role for pharmacy.

5 May 2016, HDA

 

The HDA welcomes the recent PSNC publication of plans for community pharmacy in 2016/17 and beyond as a credible and thoughtful set of proposals that as an Association we would urge the Government to consider.

 

Parliamentary Coverage

House of Commons, Written Answers, Drugs, 4 May 2016

 

Asked by Frank Field (MP): If his Department will reconsider the Medicines and Healthcare Products Regulatory Authority exemption which prior to 2013 enabled organisations to send surplus medicines to (a) developing countries and (b) other countries outside of the EEA.

 

Department of Health

 

Answered by George Freeman (MP): The Medicines and Healthcare products Regulatory Agency is the government body responsible for the safety and licensing of human medicines in the United Kingdom. The supply of a medicine for human use by way of wholesale requires the holding of a wholesale dealer’s licence. Following the transposition of the European Falsified Medicines Directive, the provisions of which are intended to prevent counterfeit medicines from entering the regulated supply chain, this requirement was extended to the export of medicines outside of Europe by way of wholesale from October 2013. The Directive does not allow any exception or exemption from this requirement.

 

House of Commons, Written Answers, Pharmacy; Finance, 4 May 2016

 

Asked by Michael Dugher (MP): If he will make an assessment of the effect of the budget reduction for community pharmacy in 2016-17 on high street vacancy rates.

 

Department of Health

 

Answered by Alistair Burt (MP): Community pharmacy is a vital part of the National Health Service and can play an even greater role. In the Spending Review, the Government re-affirmed the need for the NHS to deliver £22 billion in efficiency savings by 2020/21 as set out in the NHS’s own plan, the Five Year Forward View. Community pharmacy is a core part of NHS primary care and has an important contribution to make as the NHS rises to these challenges. The Government believes efficiencies can be made without compromising the quality of services or public access to them. Our aim is to ensure that those community pharmacies upon which people depend continue to thrive and so we are consulting on the introduction of a Pharmacy Access Scheme, which will provide more NHS funds to certain pharmacies compared to others, considering factors such as location and the health needs of the local population.

 

Full Coverage

Further details of pharmacy contract change proposals published

4 May 2016, Good Health Suite

 

Pharmacy organisations have learnt more about the proposals to change the community pharmacy contract at a Department of Health briefing.

 

A meeting on April 28 took place for pharmacy stakeholders at which the Department of Health addressed proposals in its Community Pharmacy Review. Discussions centred around the themes of the proposed Pharmacy Integration Fund, the Pharmacy Access Scheme, and issues around quality and services.

 

A background pack prepared for pharmacy stakeholders by the Department and the Department’s presentation slides have been made public. The background pack includes an interim summary of consultation responses (submitted to NHS England and the DoH up until February 12) as well as ‘source papers’ that were produced to inform initial discussions with the PSNC. “These ‘source papers’ were shared on a confidential basis with PSNC in February, and are now historic, but they will provide useful context for pharmacy contractors and other stakeholders,” said PSNC.

 

The Pharmacy Integration Fund has been proposed to support work across primary care and to involve pharmacy services in primary care settings such as GP surgeries and care homes. The funding would target aspects such as medicines optimisation, while developing infrastructure support with aspects including workforce development, digital integration and referral pathways.

 

Among concerns acknowledged by the Department were questions over the sustainability of funding, whether pharmacists employed by general practice is going to be the only form of integration, and whether there could be conflicts of interests in supplying care homes. The Department has indicated that it will now establish governance arrangements for allocation of the Pharmacy Integration Fund and confirm the legal framework.

 

In terms of funding and the Pharmacy Access Scheme, the Department said it proposed to phase out the establishment payment over a number of years, removing around £25,000 per year for all pharmacies dispensing 2,500 or more prescriptions a month. In addition, the proposed Pharmacy Access Scheme “will provide more NHS funds to certain pharmacies compared with others, considering factors such as location and the health needs of the local population.” In addition, there will be a simplified NHS pharmacy remuneration payment system based on a single activity fee.

 

“We propose that a pharmacy access scheme would be a centrally-determined national scheme with two key elements,” said the Department. “These two elements combined would determine which pharmacies should be protected, which would be published in a list:

 

a formula based on population and pharmacy location data as well as population size and needs, which would be used to generate an index of pharmacies, giving a ‘score’ of importance for patient access for each pharmacy in England;

qualification criteria based on the index of importance for patient access, and used to set a fixed criteria for entry to the scheme, such as “a score of higher than ‘x’ on the index, or the top 1,000 pharmacies etc”.

Among those invited to the meeting were Pharmacy Voice, representing pharmacy owner organisations, the Royal Pharmaceutical Society, the Local Government Association, the General Pharmaceutical Council, the Association of Pharmacy Technicians (APTUK), and National Voices, the coalition of healthcare charities in England.

 

PSNC had published a set of counter proposals ahead of the meeting, and has since said it will publish further information shortly on the counter proposals it submitted to the Department and “proposals for a quality payment to be included within the Community Pharmacy Contractual Framework.”

 

The National Pharmacy Association will host a webinar, ‘Cuts and Efficiencies: The Facts’, on the evening of May 12. Among the questions to be addressed in the free online webinar will be:

 

  • what does a 6% cut in remuneration actually mean?
  • could pharmacies be forced to close, and what has the Government actually said about closures?
  • is hub and spoke actually safer, as the Government claims?
  • is being in a cluster of pharmacies a bad thing?
  • are the Government’s proposals driven by patient demand?
  • is the Support Your Local Pharmacy campaign having an effect?

 

 

2016-04 Item-Level Only? A Closer Look at the Real EU-FMD Requirements

5 May 2016, Packaging Europe, Christoph Krähenbühl

 

It is almost five years to the day – 8th June 2011 – since the EU-FMD (Directive 2011/62/EU) was adopted by the European Parliament and the European Council. As we know, this ‘Falsified Medicines Directive’ set out in broad strokes the legal requirements on the stakeholders in the European Healthcare Supply Chain.

 

The Directive was followed on 19th February 2016 by the ‘Safety Features’ Delegated Regulation (DR 2016/161) alongside a Q&A document issued by the European Commission; both documents have given us much more details of what compliance with the EU-FMD means.

 

The publication has also set the end date of the three-year implementation deadline across Europe as the 19th February 2019 for at least 25 of the 28 European Member States, plus the 3 EEA countries of Iceland, Liechtenstein and Norway, in addition to Switzerland, Belgium, Greece and Italy, who have been granted a longer implementation timeline which they may, however, not wish to use.

 

Now is the time to examine the requirements more closely and understand the full impact of this important legislation. A closer look, in fact, reveals some interesting areas aside from the well-established basic requirements. One area, in particular, has so far not received much attention. This is the question of what the impact will be on the various stakeholders, other than pharmaceutical manufacturers and pharmacists.

 

The assumption so far has been that the impact would be felt particularly by the pharmaceutical manufacturers and the pharmacists, but that other stakeholders are getting off lightly by comparison – for example, in the US – where the Drug Supply Chain Security Act (DSCSA) legislation sets out a full end-to-end drugs traceability process involving all trading partners by 2023 – placing a significant obligation on all trading partners in the pharma supply chain, especially wholesalers and distributors.

 

But a closer examination of the EU-FMD requirements – especially those set out in Chapter V of the DR  – shows that the differences between the US traceability approach and the European point-of-dispense approach may be much smaller, and that there may, in fact, be a lot more to the EU-FMD requirements for wholesalers and distributors than a first glance reveals. Potentially, this will have a major impact on wholesalers, distributors and, by implication, their main trading partners – the pharmaceutical manufacturers.

 

The first concerns ‘risk-based’ verification. It is true that the EU-FMD does not require full end-to-end tracking of the medicines as they make their way through the distribution chain, i.e. it does not oblige wholesalers to systematically scan all shipments as they pass through their hands. But Article 20 of the DR clearly sets out scenarios where wholesalers will be obliged to verify the authenticity of the UI of the products in their ‘physical possession’ to ensure that the pack in question is not marked as blocked, dispensed, exported etc.

 

This applies to all returns and for all products not received directly from the manufacturer or the manufacturer’s official distributor. While this will only cover a limited share of the medicinal products flowing through the European supply chain, a quick calculation shows that the number of checks that must be carried out will not be insignificant.

 

It is also worth taking a peek across the pond to compare notes with the situation in the United States; in particular, the letters that were sent in January 2016 by McKesson and more recently by CardinalHealth – two of the three major distributors in the US supply chain – to all their pharma manufacturer trading partners. These letters deal with the obligation that will arise in November 2019, on distributors such as McKesson and CardinalHealth under the terms of the DSCSA, to verify all the saleable returns they handle. McKesson calculate that even a small percentage of returned goods mean they will need to carry out 18 million verifications every year.

 

The conclusion is that this can, realistically and cost-effectively, only be achieved if their pharma manufacturer partners do their bit; they would need to provide McKesson with the electronic data, including not only the item serial numbers, but also aggregated data up to shipment. This would allow the scan to be carried out at an aggregated level – shipper case, pallet, even shipment – to check the Unique Identifiers of all contained individual pharmaceutical item sales packs.

 

The message McKesson gives to their pharma manufacturing partners is very clear: “As your company prepares to implement your serialization solution, please be sure to consider the need for aggregation.” The Cardinal letter is even more direct: “Aggregation is necessary to efficiently provide serial numbers as part of Transaction Information and to easily move product through the supply chain. Cardinal Health expects that manufacturers will aggregate individual units up to the case level.”

 

So even though aggregation is an explicit US requirement only in the 2023 time-frame, major trading partners are issuing implicit requirements to establish aggregation and aggregated data exchange capability far earlier than the explicit legal requirement.

 

Given the comparable numbers of sales packs flowing through the European healthcare supply chain that fall under this risk-based verification requirement, it would be a fair assumption that manufacturers will start receiving ‘McKesson letters’ in the not too distant future that will ask them to seriously consider establishing the technical and process capabilities to supply their goods as well as the corresponding data in aggregated form.

 

In fact, the issue may become more urgent in Europe because of further requirements listed in Chapter V of the DR, where wholesalers would be required to scan the packs they manage systematically that extend beyond the returns use case. Article 22 – Decommissioning of Unique Identifiers by Wholesalers –deals with UIs of packs exported from Europe, whilst Article 23 recognises the need to accommodate the rich variety of processes across Europe by allowing Member States to define additional points in their national supply chains when the verification of the safety features and the decommissioning can be delegated to wholesalers.

 

How the Member States will interpret this provision is not yet clear, but given the primary aim of the EU-FMD legislation – to protect patients by closing all loopholes through which counterfeit medicines might infiltrate the legal medicines supply chain – it would be a safe assumption that national authorities will want to maximise the powers granted to them by the European legislation.

 

Likewise, whilst we don’t yet know what the details of these interactions are, it is likely that this obligation on wholesalers will, in turn, extend to pharmaceutical manufacturers. It is therefore likely that we will see bilateral agreement being sought by wholesalers with their pharmaceutical manufacturer trading partners that will demand not only the aggregation of physical products but also the provision of the corresponding data asset, including item, case, pallet and possibly shipment aggregation.

 

The conclusion is that the established view that European Requirements are item-level only is too narrow a view to take. True, the data reporting to the European Hub will be sales pack item UIs – as will the scan at the pharmacy – checking back against the connected National Systems.

 

But in order to support the physical and logical flow through the European Medicines supply chain in a cost-effective way for all stakeholders, 3C Excellis Europe are certainly advising all customers to aim their systems and processes to be aggregation-ready from the start.

 

For more information, visit www.3cintegrity.com

 

 

HDA welcomes PSNC proposals for enhanced role for pharmacy.

5 May 2016, HDA

 

The Healthcare Distribution Association (HDA UK) welcomes the recent PSNC publication of plans for community pharmacy in 2016/17 and beyond as a credible and thoughtful set of proposals that as an Association we would urge the Government to consider.

 

The HDA is particularly supportive of the suggestion for pharmacists to be responsible for emergency, out of hours, prescription provision, to eliminate the need for patients to go via a doctor for vital medicines. Our members provide emergency supplies of drugs to pharmacies across the four nations of the United Kingdom and would be well placed to support pharmacy in the delivery of such a service. It is clear that an important part of any reform of pharmacy must be enabling the sector help relieve pressures on GPs and A&E through taking an enhanced role within the NHS.

 

Another suggestion that the HDA agrees with the PSNC is the broadening of the pharmacy-led flu vaccination programme. Successful trials in areas such as London and Manchester have demonstrated that patients appreciate the flexibility and convenience of receiving their annual flu vaccination in pharmacy. HDA member wholesalers are crucial to such a scheme as they are able to deliver the vaccines to the pharmacy as and when they are required, through the twice daily deliveries offered by all our full members. This is a far more efficient model, as it avoids unnecessary storage and wastage of flu vaccines.

 

Finally, the HDA is in favour of the generic substitution service included in PSNC’s plan. The HDA’s predecessor the BAPW, supported the substitution of branded medicines for their generic equivalents during the last round of negotiations on the Pharmaceutical Price Regulation Scheme as it is a safe and efficient way for the NHS to save money on its medicines bill. As new innovations are introduced by pharmaceutical manufacturers it is increasingly important that the Government uses its scarce resources wisely, in order to deliver the best treatments for patients.

 

The HDA’s support for PSNC’s proposals is yet another example of the strength of the collaboration seen in the medicines supply chain, which sees the HDA working closely with partners at the regional, national and international level, across pharmacy, dispensing doctors and pharmaceutical manufacturers.

 

The PSNC’s counter proposal to the Government’s plans for community pharmacy in 2016/17 and beyond is available here.

HDA Media And Political Bulletin – 05 May 2016

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.

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