HDA Media And Political Bulletin – 18 February 2016
|Details published of how pharmacies in Europe will prevent falsified medicines getting into the supply chain
The Pharmaceutical Journal, Ingrid Torjesen, 17 February 2016
The Pharmaceutical Journal reports on the publication of the Falsified Medicines Directive delegated regulation. The publication gives a deadline of 9 February 2019 for drug manufacturers to implement the required 2-D barcode and anti-tampering device. While the verification will be done at the point of dispensing, wholesalers are also expected to verify medicines at higher risk.
There is no Parliamentary coverage today.
|RPS ‘gravely’ concerned over lack of data to support proposed 6% cuts to community pharmacy
The Pharmaceutical Journal, Julia Robinson, 17 February 2016
The Royal Pharmaceutical Society (RPS) says it “cannot support” the proposed 6% cut to community pharmacy funding because of the lack of evidence justifying why the efficiencies are needed.
In its submission to the consultation on the government’s proposals, the professional leadership body for pharmacists says that it is “gravely concerned” that the absence of an impact assessment could mean that the cuts will not deliver the desired efficiency savings and could instead be “harmful” to patients.
“There is no clarity as to whether there will be further cuts to the global sum in future years,” says the RPS, “or if there will be any fundamental changes to the contract itself, which could destabilise the sector and lead to uncertainty and a lack of investment for the future.”
Responding to predictions that 3,000 pharmacies in England could close as a result of the cuts, the RPS recommends an “immediate change to the control of entry regulations to encourage mergers of pharmacies and prevent new pharmacy premises from opening unless a local Pharmaceutical Needs Assessment (PNA) has identified a further need”.
Sandra Gidley, chair of the RPS English Pharmacy Board, says the best outcome for community pharmacy now would be for the government to pause the negotiations
Sandra Gidley, chair of the RPS English Pharmacy Board, told The Pharmaceutical Journal that the best outcome for community pharmacy now would be for the government to pause the negotiations. “A win would be for the government to say, ‘OK, we take your concerns, we want to get this right. Let’s have a proper discussion with all the pharmacy bodies to work out what we want, what’s possible and the size of the [community pharmacy] network needed to achieve that’,” she says.
Gidley explains that the RPS is keen that supply and clinical services, such as managing long-term conditions, are adequately funded. She says that this would “reassure” community pharmacists that the government does see them as “highly valued members of the primary healthcare team”.
She says the RPS has concerns about the pressure on a smaller pharmacy network and whether it would be able to deliver the clinical services that the government want. “There would need to be a mechanism by which mergers could happen without pharmacies being concerned that an opponent would just open up another pharmacy,” she adds.
In its response, submitted on 12 February 2016 to the Department of Health, the RPS outlines how the “unique” skills of pharmacists should be utilised to establish “new ways of delivering high quality pharmaceutical care” within the multidisciplinary team. These include providing “intensive support” for the elderly and those with long-term conditions, being the first contact for urgent care and providing better access to effective treatments across a variety of care settings.
“The best contribution that pharmacists can make to NHS efficiencies is their role in medicines optimisation and prevention of ill health,” it says.
Gidley said the short timescale given to put together the RPS’s response was “very frustrating” but that it was able to use its reply to the 2014 NHS England’s ‘Call to action’ for community pharmacy consultation as the basis to its response.
The consultation on the government’s proposals for community pharmacy is set to run until 24 March 2016.
The Pharmaceutical Journal, Ingrid Torjesen, 17 February 2016
An EU regulation that heralds a new system designed to prevent falsified medicines getting into the supply chain has been published by the European Medicines Agency and the European Commission.
The delegated regulation, which appears in the Official Journal of the European Union, follows the EU directive (2011/62EU) originally published in July 2011, which aimed to tighten controls against medicines containing low quality ingredients or drugs in the wrong dosage finding their way into the supply chain and impacting patient safety.
Publication of the regulation is significant, according to Sid Dajani, a member of the Royal Pharmaceutical Society (RPS) English Pharmacy Board, as it marks the start of the countdown for implementation of “pack-level safety features” and the creation of a “national medicines verification service”.
Drug manufacturers have been given a deadline of 9 February 2019 to introduce two new safety features — a unique identifier (a two-dimensional barcode) and an anti-tampering device — on the packaging of most prescription medicines and some non-prescription products. The features are intended to guarantee the drug’s authenticity.
The specific products to carry these features will be determined by each individual EU member state. Countries which already have their own medicines authentication systems, such as Belgium, Greece and Italy, have been given extra time to move to the new system.
Verification of medicines bearing these safety features will be expected to take place at the point of dispensing. Wholesalers will also be expected to verify specific medicines thought to be at higher risk of falsification in order to reduce the possibility of these products getting into the supply chain and staying there undetected.
The checks made at the point of dispensing will confirm that the product is authentic, that the anti-tampering device is still intact and the original packaging is still in place.
It’s important to ensure the changes don’t put too much pressure on pharmacists, however, says Dajani. “[Pharmacists] will be the ones implementing this and we need to ensure what’s implemented doesn’t increase risk through excessive workload or bureaucracy, increase waste or introduce risk in other areas of our practice.”
Dajani adds that it is also important that any new ways of working don’t delay the supply of medicines to patients. “Having an efficient system is a must,” he says.
Product barcodes will need to be checked to make sure that the unique identifier is listed in a repositories system to confirm that the medicine comes from a legitimate manufacturer. The unique identifier will contain the product code, the national reimbursement and identification number, the batch number and expiry date.
According to the delegated regulation, the stock checks are expected to take place well before the medicines are dispensed to prevent delays in day-to-day operations. “It should be possible for the member states to allow persons authorised or entitled to supply medicinal products to the public operating within healthcare institutions to perform the verification of the authenticity and the decommissioning of a unique identifier earlier than the time the medicinal products is supplied to the public,” it says.
When the product is supplied to the public, or is distributed outside the EU, the unique identifier on that pack will be decommissioned in the repositories system.
Drug manufacturers will be expected to set up, manage and fund the new system across all EU and European Economic Area countries under the supervision of their member states’ “competent authorities”.
NPA, 17 February 2016
The campaign to secure the future of local pharmacies is to take on a new intensity with the launch of a petition to the Prime Minister. Full details will be revealed later this week.
The national pharmacy bodies coordinating the campaign identified the need for a petition of this kind, to complement the parliamentary e-petition which has already gathered tens of thousands of signatures.
Meanwhile, over 100,000 campaign postcards have already been ordered, which allow patients to request the support of their local MP.
NPA Chairman, Ian Strachan, sent this message to NPA members today:
“Today we are announcing the petition, its purpose and the stakeholders who will be instrumental in making this phase of the campaign a success.
“But first, let’s briefly recap on the campaign journey so far.
“You will recall we appealed for members and indeed all independents to write to their MPs, raising awareness of the value that local pharmacies bring to patients and whole communities. We asked you to tell your MP about how your pharmacy has added to social capital – your true stories about supporting people in crisis, about avoiding expensive hospitalisations, about being at the heart of community life. This phase is proving to be highly successful and we encourage you to continue this theme. Why not encourage your staff, your drivers, and families to write? Remember we all have a place in our community and a stake in community pharmacy.
“We then introduced our Support Your Local Pharmacy postcards – intended to fill the mail bags of MPs across England. What a success your efforts in this phase of the campaign are delivering! Many pharmacies are completing 50+ in a day and ordering more cards. Many have initiated visits by local MPs to visit the pharmacy, so well done. If you need help with the visit on the day please get in touch with the NPA team.
“That brings me to the petition phase of the campaign. It is now clear that the Government wants to abolish any front loading to the community pharmacy contract – establishment payments are clearly in their sights for cuts. This calls for an intensification of efforts to counter the Government’s misguided approach. There is already a parliamentary e-petition in circulation and I encourage you all to support it. The petition we are announcing today is different for a number of important reasons. Firstly, it is not targeted at parliament – instead it will appeal directly to the heart of Government: No 10 Downing Street. Secondly it is a paper based petition rather than an electronic petition; we know that for many people, including elderly patients, this is the preferred way to express their support.”
Full details – including the wording of the petition and the mechanism for distributing it, collating it and presenting it – will be revealed later this week.
Pharmacy Biz, Neil Trainis, 17 February 2016
The collective manoeuvre of community pharmacy against the government’s funding cuts gathered pace as Pharmacy Voice became the latest representative body to intensify its campaign to force ministers into rethinking their plans. Addressing the Sigma conference in Jamaica, Claire Ward, the chair of Pharmacy Voice, said the organisation had lodged its response to the government’s plans to reduce pharmacy’s funding by £170 million from October as well as its intention to introduce hub and spoke dispensing and click and collect medicines distribution. In the wake of a forthright reaction from the National Pharmacy Association, Pharmacy Voice produced its own blunt response with five commitments it wants ministers to fulfil, including a reconsideration of the “planned disinvestment” in community pharmacy in 2016-17 and the establishment of a “sustainable long-term settlement.” Pharmacy Voice also said it wants to see the government “invest in service transformation in the same way as for other parts of the NHS,” forge “meaningful” partnerships with community pharmacy bodies and deliver reforms to other parts of the health system to allow pharmacy to play a central role. The government put its plans for pharmacy out to consultation but that has held no sway with community pharmacy bodies who regard the consultation as unacceptable. “This consultation process is fundamentally flawed. It is a consultation which is suggesting some really sudden and arbitrary cuts in funding to the sector which is absolutely inconsistent to what the government said I wants to do,” Ward said. “It said it wants to create a service in pharmacy and in healthcare that is responsive to patient needs and delivers better patient outcomes. “But this consultation process and the way they’ve gone about it on what they propose won’t do that. In fact, it will undermine it. “We need them to understand that. We also need some real changes from the government and some commitment about what they will do both in government terms and the NHS to enable pharmacy teams to make a contribution that we all want to see.” She added: “We know the true value of the community pharmacy network and we know it is at risk from the rush and unplanned cuts to funding that will have an impact on patient access to medicines, support and advice.” Ward also urged ministers to ensure that the Integration Fund, which starts at £20 million and will have risen to £300 million by the end of its fifth year, is “a fully accessible fund for pharmacy, not across the whole of primary care. It has to be there to help, not just integrate, but also support innovation.”
P3 Pharmacy, 17 February 2016
Losses to community pharmacy as a result of government cuts could add up to anything reaching £2 billion in coming years, Day Lewis’ ceo Kirit Patel has estimated. Initiatives suggested by the DH, such as greater use of online medicines ordering and hub and spoke models, plus potential additional funding cuts in future years, would all contribute to the total, he said. “You don’t destroy a pharmacy network just for £170 million,” he said, speaking at the Sigma conference in Jamaica.
Pharmacy businesses should consider the scenario as a possibility and plan accordingly. “Plan for the worst and hope for the best,” he said. Smaller pharmacies in the “clusters” identified by the Department of Health, may want to consider merging to put themselves in a stronger position, he suggested.
Day Lewis will be using their past experiences of surviving recession and other situations to weather any storms ahead. For example, the skills of the people working in community pharmacy are key to success during this challenging period and differenting factor for your business, Mr Patel told independent pharmacy delegates. In the past Day Lewis chose to respond by focusing on staff training, and this is just as important now, he said. “We embarked on a people programme, and I feel that’s what needs to be done this time. Skill your people up.”
Growing clinical skills to successfully achieve a move from today’s dispensing model to services needs to now happen for pharmacies to survive, he said. “We need to shift our income away from dispensing to a service income. Unless we get our mental attitude correct and focus on the services you are going to find attrition on your bottom line.”
A shift to the greater use of the internet by community pharmacy is also vital, he said. “We need to learn to harness technology: you must have a website and interact with people through it. EPS is an opportunity and I suggest that you harness that. If you don’t sign up those patients they will be gone.” The potential growth of online pharmacy, encouraged by the DH, is a major threat, he said. “It won’t be long before there are some big online players.”
However, he said that he doubts that there is yet a great demand for online click and collect services for medicines. Advantages offered to customers by online shopping in other markets are price, range of products and convenience, he said. But with medicines, online offers no difference for price or for range, and convenience is also covered by local delivery services. “We have made life for patients so easy,” he commented.
P3 Pharmacy, 17 February 2016
The NPA has stepped up its defense of pharmacy against the looming government cuts with the launch of a paper petition to Prime Minister, David Cameron.
“There is already a parliamentary e-petition in circulation and I encourage you all to support it. The petition we are announcing today is different for a number of important reasons,” said NPA chairman, Ian Strachan.
“Firstly, it is not targeted at parliament – instead, it will appeal directly to the heart of Government: No 10 Downing Street. Secondly, it is a paper based petition rather than an electronic petition; we know that for many people, including elderly patients, this is the preferred way to express their support.”
The petition is just the NPA’s latest step is an “intensification of efforts to counter the Government’s misguided approach”.
Speaking at the launch of the petition, Mr Strachan praised the amount of customers that pharmacies have encouraged to send local pharmacy support postcards, saying: “We intended to fill the mail bags of MPs across England. What a success your efforts in this phase of the campaign are delivering! Many pharmacies are completing 50+ in a day and ordering more cards. Many have initiated visits by local MPs to visit the pharmacy, so well done.”
The pharmacy body had already appealed for all independents to write to their MPs to ‘raise awareness of the value that local pharmacies bring to patients and whole communities.’
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
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