News

HDA Media And Political Bulletin – 29 September 2016

Urgent need for clarity as government suspends pharmacy cut plans

27 September 2016, Pharmaphorum, Richard Staines

 

David Mowat, the Parliamentary Under Secretary of State for Community Health and Care, recently announced that the Government has suspended plans to cut funding for community pharmacy services. However, experts at an IMS Health webinar spoke about the urgent need for clarity. The panel also said the Government was attempting to re-engineer the pharmacy service, and was using the cuts as an opportunity to impose a ‘hub and spoke’ infrastructure. The Pharmacy Minister, Alistair Burt, announced that hub and spoke would not be introduced in October as previously planned, but an uncertainty over the future of these plans remains.

 

The global scourge of counterfeit medicines

29 September 2016, PMLive, Danny Buckland

 

The pharmaceutical industry and regulatory authorities are fighting back against falsified and counterfeit medicines that according to the European Commission cause approximately 100,000 deaths a year. The Alliance for Safe Online Pharmacy in the EU (ASOP EU) warns that 130 million people in Europe are risking their health by ordering medicines from illegal pharmacy websites. The implementation of the Falsified Medicines Directive (FMD) will ensure verification of drugs at manufacture, distribution and in pharmacies. Adrian van den Hoven, Medicines for Europe Director General believes that there is potential for major reputational damage from the sale of falsified medicines as persistent stories about dangerous medicines can breed mistrust.

 

Parliamentary Coverage

 

House of Commons Questions , Drugs, 27 September 2016

Department for Exiting the European Union

Andrew Gwynne: What discussions his Department has had to date with representatives of pharmaceutical companies on the UK voting to leave the EU.

Mr Robin Walker:

Ministers have met with the Association of The British Pharmaceutical Industry (ABPI), and The Secretary of State for Exiting the European Union will be attending the EU UK Life Science Steering Board. We will continue to consult with a broad range of stakeholders on the implications of the referendum result, including the pharmaceutical industry.

 

Full Coverage

Urgent need for clarity as government suspends pharmacy cut plans

27 September 2016, Pharmaphorum, Richard Staines

 

The government has suspended plans that would have put thousands of community pharmacies at risk of closure – but there is an urgent need for clarity, according to experts at a recent IMS Health webinar.

When David Mowat, the Parliamentary Under Secretary of State for Community Health and Care, announced at the beginning of the month that cuts to community pharmacy funding would not be implemented in October, the initial reaction from those affected was one of relief. However, this reaction may be short-lived, as the minister said the government has only decided to put on hold cuts that would probably lead to closure of thousands of pharmacies across the country, while the plans are reviewed.

Mowat’s announcement at the Royal Pharmaceutical Society conference in Birmingham that the government would “take some time” to ensure it is making the “right decision” followed a petition signed by more than two million people opposing the plans.

So the fight is on to secure the future of the small pharmacists that were threatened by the proposals, with one option being to increase their value within the community. Methods to achieve this include being the first point of care more frequently and offering a greater range of patient services, such as disease prevention education, adherence programme delivery and lifestyle advice.

At a recent webinar conducted by IMS Health, in collaboration with pharmaphorum (which took place prior to Mowat’s announcement), IMS Health estimated that proposed cuts of £170 million, from a pharmacy budget of £2.8 billion, could put 2,400 pharmacies at moderate-to-high risk of closure, with 269 of these deemed at very high risk.

John Carney, senior principal, supplier services at IMS Health said that the proposals could lead to “significant disruption” to between 110,000–600,000 people, assuming each pharmacy served around 4,500 people.

The webinar’s expert panel proposed that the government saw pharmacy as an easy target for efficiency savings, but made it clear that the cuts were not the only issue that caused them significant concern.

Hub and spoke

The panel said the government was also attempting to re-engineer the way pharmacies serve patients, and was using the cuts as an opportunity to impose a ‘hub and spoke’ infrastructure. This model is based around a central ‘hub’ where prescriptions are prepared – and patient-facing ‘spoke’ pharmacies that hand out treatments.

The system is already used by some larger chains and is seen by the government as a more efficient way to meet patients’ needs. But, although it works in some instances, this ‘one-size-fits-all’ approach may not be suitable for all areas and populations, and the panel warned it could result in serious reductions in the extra patient services provided by pharmacists that patients rely on, which frequently serve to relieve pressure on other areas of the NHS

In an announcement in July, pharmacy minister Alistair Burt said hub and spoke would not be introduced in October as planned – but the uncertainty over the direction of travel remains.

There are also fears that the government is attempting to introduce more online pharmacies through the back door – even though this does not suit the needs of many patients who rely on community pharmacists as a first port of call if they feel unwell.

Sandra Gidley, community pharmacist and chair of the Royal Pharmaceutical Society’s English Pharmacy Board, told the panel that she was concerned about the trajectory of governmental policy around community pharmacy. While the drive towards online services may suit some patients, those who are older and less likely to adopt new technology are the types of patient who need pharmacists the most, she argued.

Gidley said: “The depressing thing in all of this is that we see a drive to separate the supplies we make from the clinical services that pharmacists can deliver.”

Not just dispensing

Perhaps offering a crumb of comfort to Gidley, and those who have broader concerns about the wider role of pharmacists, Mowat in his speech said the pharmacy profession “rightly recognises that it needs to go further away from just doing dispensing into the service area.”

A Pharmacy Integration Fund, worth £20 million this year and rising to £300 million by 2020–21, was included in the government’s plans, and is intended to help pharmacists and their teams align more closely with GP practices. But details of whether this will still be implemented and, if so, how the scheme will work, are still unclear.

There are also concerns that the cuts to pharmacy will exacerbate problems caused by financial pressures on the NHS. Around three quarters of hospitals are operating in the red, and ran up a deficit of £461 million between April and June. Patient waiting times have increased, with 89.31% (vs. 95% target) of patients being seen within four hours in over-stretched A&E departments.

Services such as community pharmacies could, and should, become more important as hospitals and GP surgeries come under pressure, providing extra capacity that could deal with less serious illnesses.

John Smith, chief executive of the Proprietary Association of Great Britain (PAGB), said: “Our research shows that one-in-five visits to A&E and also to the GP are for conditions that could be self-treated.” The PAGB strongly backs raising the profile of pharmacists as expert healthcare providers. “We believe that, in the role of a high-street healthcare professional, not only will pharmacists enable people to obtain faster treatment but, in reducing the load on the NHS primary – and secondary – providers, they can also deliver savings to the taxpayer,” added Smith.

Changes needed, not cuts

The consensus seems to be that change – but not cuts – is needed to ensure pharmacy services meet patients’ needs and reduce pressure on the busiest NHS wards and A&E units. A recent poll by IMS Health found that 79% of respondents across industry and pharmacy said there was a need for an increased range of patient services in order for them to succeed in the changing environment.

Professor Rob Darracott, chief executive of the umbrella group Pharmacy Voice, said that “most innovation comes through interaction with patients” and argued that community pharmacists were well placed to question patients, identify other health problems and give public health advice, at no charge to the NHS.

Pharmacists already contribute with innovative services such as medicines optimisation, discussing ‘wellness packages’ and improving compliance with prescribed medication. Given that there are a billion transactions a year in community pharmacies, a relatively small change in practice across all pharmacies could yield significant results, Darracott argued.

However, pharmacy has been in turmoil since the government announced its plans in a letter to the industry’s negotiating body late last year.

Deliberations

The sector is awaiting Mowat’s conclusions following his period of deliberation. Although nothing has been officially announced, those involved with community pharmacy will listen intently during Theresa May’s first Autumn Statement, dedicated to NHS funding, for any news.

The panel of experts at the webinar concluded that the government must provide clarity on its plans. There is also a need for an end to the siloed thinking that has proposed swingeing cost cuts, with little thought about the wider implications for patients, the health service and society as a whole.

The PAGB’s John Smith concluded that the government must learn from the response to its proposals and the opposition from pharmacists and patient groups. He said: “We need a strategic approach to building the future between the sector, government and the NHS, which is aligned to the goals of the NHS, but does not leave implementation and delivery to chance.”

Ultimately, though, whatever the government’s next move is regarding these cuts – this is a clear message to the pharmacy sector that its role within the NHS must be more visible to patients and more extensive. As with many of the issues the UK health sector faces, a large part of the solution lies in stakeholder and patient collaboration/education and a clear, measured understanding of the value that the pharmacy sector brings to both the care pathway and the NHS budget.

 

The global scourge of counterfeit medicines

PMLive, 29 September 2016, Danny Buckland

 

The statistics are truly disturbing, with an annual death toll of around 100,000 from falsified and counterfeit medicines, according to the European Commission, and a criminal enterprise that the World Customs Organisation estimates could generate £1bn worth of illicit business in 2017.

But industry and regulatory authorities are fighting back with new measures to identify rogue shipments and coordinated action to disrupt the supply lines that criss-cross the globe.

The trend to seek medical aid online has made it easy for bogus medicines – containing anything from paint and antifreeze to brick dust and floor wax – to be mailed around the world. The Alliance for Safe Online Pharmacy in the EU (ASOP EU) warns that 130 million people in Europe are risking their health by ordering from the 30,000 illegal pharmacy websites that have flooded the Internet

Industry also has to consider the damage to its reputation from the corrosive impact of falsified and counterfeit medicines. ‘Fighting Counterfeit Medicines’ was debated at the recent Medicines for Europe conference (MFE) in Croatia, which drew together the leading voices in generic medicines.

A major concern is that generic medicines may be confused with substandard medicines peddled by criminals to a public struggling to understand the scale of the problem.

Delegates learned about increased safety features that will be implemented by February 2019 in the European Commission’s Falsified Medicines Directive (FMD) which boosts verification at manufacture, distribution and pharmacy. Its features include unique serial numbers and identification features on packs, tougher inspections, strengthened record-keeping and an EU logo to signify legal online pharmacies.

A key element is that the FMD will criminalise the acts of making and selling bogus medicines to create a credible deterrent.

The measures were further bolstered by a strategy meeting held at Google’s offices in Brussels, where campaigning groups and regulators joined forces to face the threat head-on. The group will meet again in September to share best practice and build on plans to address the ‘knowledge demand’ by raising public awareness, as market research reveals the public is largely ignorant to the dangers of buying medicines online.

The reputational damage is clear, according to Adrian van den Hoven, Medicines for Europe director general, because persistent stories about dan-gerous medicines can breed mistrust. Elke Grooten, an MFE board member told the conference: “It is important that we have these discussions in an international context because falsified medicines put patients and the general public at risk across the world – it is a crime against patients.[Industry must] repel the tide of dangerous internet medicines that operates outside the legitimate supply chains

“It is also an issue for healthcare providers caring about their patients because falsified medicines create mistrust in medicines and it is an issue for us as pharmaceutical companies developing and manufacturing high quality medicines – it affects all medicines.”

Van den Hoven highlighted that the new system, working in harmony with industry, will serialise 14 billion prescription drugs a year and enable pharmacies and hospitals to spot counterfeits.

“There have been serious issues. About a year ago there was a theft of empty vials and bottles from a hospital in Italy which were refilled with a liquid and exported to Austria and Germany in quite substantial amounts for serious treatments like cancer,” he said.

“There was an issue of trying to find those products because they disappeared and then reappeared in two different countries through completely illegal trading. They were found and to my knowledge didn’t reach patients but the investigation is still continuing and it was still a scare. The new system will make it extremely difficult for this to happen.”

Mike Isles, executive director of ASOP EU, believes the FMD clampdown must be matched by a twin effort to repel the tide of dangerous internet medicines that operates outside the normal and robust legitimate supply chain.

“It is a massive problem with 18% of the population going online to buy medicines and potentially endangering their lives,” he said. “These sites do not require a prescription and their medicines may have no active substance, too little or even too much. And they may contain toxic substances like floor wax, paint or antifreeze.

“Customers also risk having their credit card details stolen. The problem is that most people do not know these websites are operating illegally.”

He also feels industry, with its significant reach, can play an important role in educating healthcare professionals.

“The benefit is that it will help to prevent patients taking themselves out of their national health systems and potentially damaging their health. Industry is reacting well and has dedicated security people who are the first line who go into a country, compile the evidence and then pass it on to local law enforcement and customs, enabling Interpol or Europol to get involved.”

He added that Google is supporting information campaigns in Europe and the US to help educate patients to enable them to move away from bogus sites and is working on techniques to ensure only legitimate pharmacies are shown in online searches.

An educational campaign by ASOP EU and the European Alliance for Access to Safe Medicines, using Google AdWords to attract online buyers in Italy, revealed that 80% of people were unaware that the majority of online pharmacies operate illegally. A large majority said they would revert to their doctor or pharmacy after learning about the danger.

On the supply side, the task of catching the criminals is huge but Interpol, Europol, national customs’ forces, governments and credit card firms are engaging in the fight.

80% of people are unaware that the majority of online pharmacies operate illegally

An Interpol-led investigation earlier this year closed 4,932 sites and seized 12.2 million counterfeit drugs for cancer, depression, asthma and high cholesterol, along with slimming pills, infertility drugs and bodybuilding steroids. The crackdown across 103 countries resulted in 393 arrests.

Benoit Goyens, of the World Customs Organization (WCO), told the conference that the global value of illegally traded medicines could stretch to £1bn, adding: “The growth is exponential and we are not catching up.”

Research by ASOP EU highlighted that 65% of the public order online believing they are connecting with reputable pharmacies. The number of people using online sites for medical help is growing and ASOP estimated that some gangs haul in £1m in profit a month.

Pharmaceutical products now account for more than half of all goods seized, according to the WCO which reported that painkillers were the most frequently intercepted illicit drug at 36,324,200 in 2014. More than half of the 95,273,060 counterfeit medicines impounded last year came from India and China. Among the seizures was a supply of erectile dysfunction pills that contained a drug that could cause kidney failure.

Crime gangs are attracted to illicit drugs because the profits are high and sentences are rarely more than token fines.

The WCO has launched smart-phone technology to help identify and track shipments, and drugs firms, credit card companies and internet registers have pledged to disrupt the crime gangs’ deadly supply chain.

“This is a widespread and profitable criminal activity, and tackling it requires strong cooperation from all those involved in the pharmaceutical supply chain,” said Pierluigi Antonelli, head of the Western Europe region for Sandoz. “Falsified medicines are responsible for the deaths of thousands of people every year and risk the health and safety of many more.

“We support and drive a range of measures to increase patient awareness of the risks of falsified medicines, increase penalties and sanctions for counterfeiters, close illegal pharmacy websites, introduce serialisation of the legal distribution chain and increase regulatory actions to seize falsified medicines.

“We also strongly urge all concerned to avoid misleading and inaccurate comparisons between illegal falsified medicines and legally authorised, high-quality generic medicines produced by recognised pharmaceutical companies following loss of patent protection. Generic medicines account for 56% of all pharmaceutical prescriptions in Europe today, but only 22% of the cost.”

The fight is on for the health and safety of the public and the pharmaceutical industry’s reputation.

HDA Media And Political Bulletin – 29 September 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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