Media and Political Bulletin – 03 August 2020

Media and Political Bulletin

03 August 2020

Media Summary

Medicine shortages have been affecting EU citizens’ health for too long

New Europe, Alessandra Moretti, 03 August 2020

Italian MEP and member of the European Parliament Committee on the Environment, Public Health and Food Safety (ENVI), Alessandra Moretti, writes in New Europe that the Committee approved the July 14 NI Report on the shortage of medicines.

The report reaffirms the need to address the root causes of medicines shortages and calls for a more impactful EU response to face this very complex issue. All the main political groups have agreed that this problem cannot be solved by individual actions at the national level, and thus that a more coordinated initiative from EU authorities will be required.

The approved text further highlights that “no Member State is self-sufficient with regard to raw materials, intermediates, active pharmaceutical ingredients (APIs) and finished medicines that are necessary to guarantee the proper functioning of the health system.”

The report also highlights the need for national authorities and the private sector to also be held responsible. Finally, Moretti points to the request for shortage prevention and risk management plans to be prepared by relevant actors in order to better prepare for a possible risk of shortages, particularly for those medicines for which no alternative exists at the moment.

Parliamentary Coverage

European Union Committee, 28 July 2020

On 28 July 2020, the European Union Committee convened virtually to discuss the Protocol on Ireland/Northern Ireland. The Committee heard evidence from Robin Walker MP, Minister of State, Northern Ireland Office on the measures being taken to prepare for the implementation of the Protocol.

The full virtual meeting can be accessed here.

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Medicine shortages have been affecting EU citizens’ health for too long

New Europe, Alessandra Moretti, 03 August 2020

The July 14 NI Report on the shortage of medicines was approved by the ENVI Committee in the European Parliament, addressing the root causes of medicine shortages and calling for appropriate responses on different levels. Unfortunately, there are still too many patients in Europe that cannot access treatment because the drugs they need are not available. Therefore, an EU wide response has been long-awaited by patients, researchers, doctors, and the private sector.

The report was the result of intense and very delicate negotiations among different political groups, which was also complicated by a very tight timeline. Overall, the text is a balanced and comprehensive call by the European Parliament to address this very sensitive issue.

In general terms, some important results have been included in this dossier, including the reaffirmed right to healthcare for everyone, strengthening of the role of the European agencies responsible for public health, and the confirmation of the fundamental role of research and innovation.

More specifically, on shortages, the report reaffirms the need to address the root causes of medicines shortages and calls for a more impactful EU response to face this very complex issue. All the main political groups have agreed from the beginning that this problem cannot be solved by individual actions at the national level, and thus a more coordinated initiative from EU authorities will be required.

In recent years, it has been clear that “no Member State is self-sufficient with regard to raw materials, intermediates, active pharmaceutical ingredients (APIs) and finished medicines that are necessary to guarantee the proper functioning of the health system”, as can be read in the text that was just approved. Therefore, EU action is needed to restore European independence in terms of medicines and treatment, by, for example, bringing back the production of many APIs for which the EU is now dependent on the strategic choices of other countries with the objective of making medicines available, affordable, sustainable, and equally accessible to everyone in the EU, regardless of their country of residence.

In order to do so, the keyword in this report is responsibility. Responsibility for national authorities, which must provide an efficient regulatory environment and plan ahead in terms of preventing deficiencies. The report demands that the Commission and the EMA have an enhanced coordination role, with precise powers, a broader mandate, and enhanced staff.

At the same time, the report states clearly the responsibility of the private sector. which must do its part, and do it better. Pharmaceutical companies, market authorisation holders, and wholesale distributors have a fundamental responsibility to the proper functioning of the supply chain. While recalling the importance of the provisions included in the Directive 2001/83, the report criticises the “disparities observed by the Commission in the transposition of these obligations into national legislation” and calls on the Commission to make sure that market authorisation holders and wholesale distributors comply with the requirements of the directive to ensure appropriate and continued supplies of medicines, while also asking for “dissuasive and proportionate sanctions in case of non-compliance”.

Another very important point is the request for shortage prevention and risk management plans to be prepared by the relevant actors in order to better prepare for a possible risk of shortages, particularly for those medicines for which no alternative exists at the moment.

The activation of emergency plans, which can act as a rapid and timely alert tool on the shortage risk – either current or potential – of certain drugs, could be useful in order to limit as much as possible deficiencies. These plans could help provide a constantly updated picture of the availability of certain medicines in Europe and could be vital for the public authorities to foresee timely intervention in case of possible shortage risks.

Moreover, the report asks for the issue of storage at Member State level to be addressed at EU level. We cannot allow the Member States to move freely on such a sensitive issue, without coordination and perhaps by competing with each other, and this was included in the text.

To conclude, we know, unfortunately, that medicine shortages have a direct impact on patients’ health, on their safety, the continuation of their treatment and their life expectancy, placing the lives of too many people in Europe at risk.

Medicine shortages have been affecting EU citizens’ health for too long already, but the COVID crisis has sharpened the hardship on this. The recent crisis has demonstrated again the importance of a strong Europe able to protect its citizens, even in healthcare.

In this sense, the Socialist & Democrats Group has proposed a comprehensive plan for the creation of a genuine European Health Union, a plan that would enhance UE ability to protect its citizens also in health matters. This is for us the final objective, but we can consider this first report on shortages as a first concrete step in the right direction to build a safer and fairer Europe for everyone.

Hard Brexit could deprive Ireland of key medicines

The Times, Ellen Coyne, 31 August 2017

 

Pharmaceutical body, Medicines for Ireland, which represents the country’s largest drug suppliers, warned that Irish patients could face drug shortages after Brexit and costs could rise while drugs with a short shelf life could be at risk of expiring if they were delayed by border checks. Stakeholders have been invited to examine the impact on the sector of Britain’s decision to leave the EU at a Health Products Regulatory Authority event today. Ireland has been able to share batches of medicines with Britain but could in the future face problems accessing drugs because the country’s population is too small to buy in bulk.

 

The warning was also covered by The Irish Times.

 

Life Sciences Industrial Strategy Report

UK Government, 30 August 2017

 

The strategy report set outs a plan for the British medical industry to become a global powerhouse after Brexit. A pre-announcement released overnight heralds £160 million of funding across basic science, clinical and technology research and collaboration with the NHS. Only £14 million of this appears to be new funding, with the remaining £146 million coming from an industrial challenges fund announced at the start of the year.

 

There are five priorities: science, infrastructure, the NHS, data and skills, according to the independent panel headed by Professor Sir John Bell that put together the strategy. It confirms the Accelerated Access Review proposal, to fast-track treatments from the lab to patients, will be adopted. A handful of hubs will be set up to share medical data, and tax rules altered to aid private investment. The strategy will also set out plans to ensure “the U.K. has the talent and skills to underpin future life sciences success,” the government said. The first UK Life Sciences Strategy since 2011, the report signals a continued favourable focus of the UK Government on the sector.

 

The ABPI welcomed the publication of the Strategy commenting: “Today’s Life Sciences Industrial Strategy is an impressive document which captures the importance of our sector to a successful post-Brexit Britain.”  ABPI CEO Mike Thompson stated: “The NHS is rightly at the heart of the strategy: If it can build on its unique capability to use health data in research and development and address the UK’s long-standing challenge of adopting new treatments, it will create a virtuous circle for all and deliver massive health and economic benefits to the UK.”. The full statement is available here.

 

The strategy was largely covered in national and specialist media outlets including BBC NewsThe GuardianThe Daily TelegraphReutersCity AMPharma Times and pharmaphorum. Media coverage picked up on the NHS being a central theme of the report with references to the role that technology should play in transforming healthcare for patients and shaping a completely new industry. While The Guardian focused on the potential privacy issues that surround the extensive use of data, Reuters emphasised the pharmaceutical sector’s focus on ensuring that the UK remains “open for innovation as it prepares to exit the EU”.

 

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

Hard Brexit could deprive Ireland of key medicines

The Times, Ellen Coyne, 31 August 2017

 

Irish patients could face drug shortages after a hard Brexit, a pharmaceutical body has warned.

 

Medicines for Ireland, which represents the country’s largest drug suppliers, said that costs could rise while drugs with a short shelf life could be at risk of expiring if they were delayed by border checks.

The group will set out a series of negative consequences that Irish patients could face at a Health Products Regulatory Authority event today. Stakeholders have been invited to examine the impact on the sector of Britain’s decision to leave the EU.

 

Sandra Gannon, general manager of Teva Pharmaceuticals Ireland and chairwoman of the group, said that Britain leaving the customs union and single market would be the “worst case scenario” for patients and manufacturers because there was no reason to think that the present regulatory structures would remain in place.

 

“In fact, it would signal strongly an intention for the UK to apply its own standards and regulatory requirements,” she said.

 

Ireland has been able to share batches of medicines with Britain but could in the future face problems accessing drugs because the country’s population is too small to buy in bulk.

 

“The issue of medicine shortages is another concern. Already, 140 medicines are out of stock and we are at risk of further shortages due to Ireland’s dependence on the much larger British market,” Ms Gannon said.

 

“Without the ability to batch-share, the small size of the Irish market may make it commercially unsustainable for manufacturers to supply to Ireland. That would seriously damage Ireland’s interests both in terms of patient access to medicines and the inevitable rise in cost which would occur.”

 

The British government said that it wanted a hard Brexit but has not set out in detail what kind of customs and border arrangements it was considering.

 

Medicines for Ireland said that every hour of a customs delay in the event of a hard border would increase the cost of drugs, which would have an impact on the health service and patients.

Brexit could cause drug shortages – wholesalers

17 June 2016, pharmaphorum, Richard Staines

 

Pharmaphorum explains that the HDA, as part of its Annual Conference newsletter, stated a ‘Brexit’ could compromise the UK’s supply of medicines, drive up prices, and result in shortages becoming much more acute. It added that the industry was regulated by a one over-arching set of laws on Good Distribution Practice, a ‘Leave’ vote would mean the Medicines and Healthcare Products Regulatory Authority would become solely responsible for regulating the UK. Pharmaphorum noted that the HDA did not explicitly express support for the ‘Remain’ or ‘Leave’ campaign.

 

NHS England may be thinking of decommissioning MURs and new medicine service, PSNC fears

17 June 2016, The Pharmaceutical Journal, Elizabeth Zukkar

 

The Pharmaceutical Journal reports on Alastair Buxton, director of NHS Services at PSNC, expressing his concerns that findings of a review into clinical pharmacy services may be used to decommission the medicines use review (MUR) service. A PSNC spokesperson commented that while this is their concern, “we don’t know if that is the government’s intention”. Buxton added that pharmacy was “fantastically” efficient, although the Department of Health thought it could be more so.

 

UK pharma contributes £1.3bn to NHS meds bill

20 June 2016, Pharma Times, Selina McKee

 

Pharma Times reports that the UK pharmaceutical industry has now contributed £1.3 billion to underwrite growth in the NHS medicines bill, but overall spend remains flat. Companies who are voluntarily signed up to the Pharmaceutical Price Regulation Scheme (PPRS) have handed over £367 million between September 2015 and March 2016, taking total payments to £1.296 billion.

 

The full details of payment to the Department of Health (DH) under the five-year Pharmaceutical Price Regulation Scheme (PPRS) published by the ABPI are available here.

Parliamentary Coverage

 

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Brexit could cause drug shortages – wholesalers

17 June 2016, pharmaphorum, Richard Staines

 

A “Brexit” could compromise the UK’s supply of medicines and drive up prices, according to pharma wholesalers.

 

The Healthcare Distribution Association (HDA UK) said in its conference newsletter that proposals by many supporters of the ‘Leave’ campaign to opt out of the EU single market would cut off the supply of parallel imports of medicines.

 

Shortages could “become much more acute” if the UK leaves the EU. As it is, the country has always been a net importer of medicines from the EU.

 

This legal parallel trade provides medicines “at short notice and at a reduced cost”, HDA UK said.

 

Many wholesalers source medicines from the EU and this process is made much easier by one over-arching set of laws on Good Distribution Practice.

 

HDA UK said that leaving the EU, and having another set of GDP regulations for the UK, would drive up prices.

 

“The cost implications could be significant if the UK was to have a different set of regulations to the rest of the EU,” HDA UK said.

 

The pharma supply chain is largely regulated by the EU and a ‘Leave’ vote would mean the Medicines and Healthcare Products Regulatory Authority would become solely responsible for regulating the UK.

 

However HDA UK did not explicitly say whether it supported the ‘Leave’ or ‘Remain’ campaign.

 

Pharma and biotech trade bodies and companies have backed the ‘Remain’ campaign, arguing that a Brexit would dismantle regulatory arrangements, and that the increased costs would discourage pharma from investing in the UK.

 

NHS England may be thinking of decommissioning MURs and new medicine service, PSNC fears

17 June 2016, The Pharmaceutical Journal, Elizabeth Zukkar

 

Alastair Buxton, director of NHS services at the PSNC, told the HDA conference he has concerns that a review into clinical pharmacy could lead to services being cut.

 

Alastair Buxton, director of NHS services at the PSNC, told the HDA conference that the PSNC has concerns that services could be cut after a review into clinical pharmacy

 

The Pharmaceutical Services Negotiating Committee (PSNC) has expressed concerns that the findings of a review into clinical pharmacy services may be used to decommission the medicines use review (MUR) service.

 

Speaking at the Healthcare Distribution Association’s (HDA) annual conference on 16 June 2016 in London, Alastair Buxton, director of NHS services at the PSNC, said he was concerned about the “direction of travel” of the review. He said the PSNC, which negotiates the community pharmacy contract with the government, was worried that the review was about “getting rid” of MURs and the new medicine service (NMS).

 

After the conference, a PSNC spokesperson added that while this is their concern, “we don’t know if that is the government’s intention”.

 

The MUR service has had some bad press recently after The Guardian ran a story in April 2016 alleging that Boots was putting pressure on pharmacists to undertake unnecessary MURs. The Pharmaceutical Journal also reported on concerns about pressures placed on pharmacists to undertake MURs in 2013.

 

Gordon Hockey, a barrister who works for the PSNC, says the PSNC was worried the review was only looking at MURs, and not other locally commissioned services, such as emergency hormonal contraception services. “If you want to look at clinical services, you need to look at the full package. The PSNC has suspicions that the review will knock MURs,” says Hockey.

 

The independent review of community pharmacy services was commissioned by NHS England to make recommendations for future commissioning models for community pharmacy and the pharmacy workforce. It is being led by Richard Murray, director of policy for the King’s Fund, and is expected to be completed by October 2016.

 

When asked whether the review was looking into removing MURs or NMS services, Keith Ridge, chief pharmaceutical officer, said: “This review will provide one additional source of information on how clinical services provided by pharmacy teams could be redesigned to bring these teams even closer to patients and to the heart of the NHS. This work is one contribution to broader action to help modernise NHS pharmacy services, and to meet the changing shape and demands of healthcare.”

 

According to NHS England, the main areas for consideration in the review will be: meeting the changing healthcare needs of an ageing population; ensuring patients receive the best outcomes from medicines; and integrating community pharmacy into emerging new models of care as the NHS implements its ‘Five year forward view’. The review will also look closely at the barriers that prevent the best use of pharmacy team skills in the care of patients with acute and long-term conditions, it adds.

 

Speaking on the pharmacy cuts announced in December 2015, Buxton told the conference that pharmacy was “fantastically” efficient, although the Department of Health thought it could be more so.

 

He recognised that there were clusters of pharmacies, especially so after the deregulation of the market in 2005, but predicted that the government would defend itself by saying that another government was in power then.

 

Clusters of pharmacies in large population areas are hard to defend because they do exist, said Buxton, but clustering is not wrong since many community pharmacies deliver services based on patient needs.

 

UK pharma contributes £1.3bn to NHS meds bill

20 June 2016, Pharma Times, Selina McKee

 

The UK pharmaceutical industry has now contributed £1.3 billion to underwrite growth in the NHS medicines bill, but overall spend remains flat.

 

Companies who are voluntarily signed up to the Pharmaceutical Price Regulation Scheme (PPRS) have handed over £367 million between September 2015 and March 2016, taking total payments to £1.296 billion.

 

Under the 2014 PPRS, the industry agreed to pay a rebate when NHS spend on branded medicines exceeds pre-agreed growth rates, to help support use of innovative new treatments at minimal cost.

 

But despite this industry funding, NHS spend on branded medicines covered under the scheme has remained flat over the six-month period, as new medicines approved as clinically and cost effective by NICE are not always adopted by the NHS locally.

 

“Medicines spend under the PPRS is lower than anticipated when the scheme began, however the scheme remains important overall in helping the Department of Health and the NHS budget for medicines,” noted David Watson, Director of Pricing and PPRS at the Association of the British Pharmaceutical Industry.

Most medicines don’t suffer shortages, claims government

13 June 2016, Chemist and Druggist, Annabelle Collins

 

In response to Kevin Barron calling for a meeting with Alistair Burt to discuss stock shortages, the Department of Health (DH) has stressed that the “vast majority” of prescriptions are not subject to supply problems. A DH spokesperson added that it was working closely with members of the supply chain to mitigate the impact of shortages on patient care. It stated it would “respond fully to [the letter] in due course.”

Parliamentary Coverage

 

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All-Party Pharmacy Group calls for action on drug shortages

10 June 2016, The Pharmaceutical Journal

 

The Pharmaceutical Journal also reports on Sir Kevin Barron, chair of the APPG, calling for the Government to do more to tackle the issue of drug shortages in the UK. The group calls for the Department of Health, the MHRA and NHS England to establish a monitoring system to help reduce the impact of shortages on patients.

 

Shock news: The government may actually ‘consult’ the sector

10 June 2016, Chemist and Druggist, James Waldron

 

Chemist and Druggist comments on the Government’s decision to delay hub and spoke dispensing plans, to take more time to explore the responses to its consultation in more detail. It points out that the sector has often cited this change as a possible way to “level the playing field”, but has expressed concerns that automated dispensing would come to the expense of patient interactions. Ultimately, this delay demonstrates the necessity for the Department of Health to consult with the sector before implementing change.

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All-Party Pharmacy Group calls for action on drug shortages

10 June 2016, The Pharmaceutical Journal

 

The All-Party Pharmacy Group (APPG) has repeated its call for more to be done to tackle medicines shortages, after over half of community pharmacists responding to a survey said they dealt with drug shortages on a daily basis.

 

In a letter to Alistair Burt, the minister for community and social care, the group calls for the Department of Health, NHS England and the Medicines and Healthcare products Regulatory Agency to establish an early warning system to monitor and detect drug shortages, to help reduce the impact of shortages on patients.

 

Sir Kevin Barron, APPG chair, says the amount of time healthcare professionals are having to spend on dealing with medicines shortages is “damaging”

 

“It’s clear that at a time when the NHS needs to be making the very best use of its valuable resources in order to maximise efficiency and productivity, the time healthcare professionals are having to spend on dealing with shortages is damaging,” says Sir Kevin Barron, chair of the APPG.

 

In the survey, 48% of community pharmacists said they spent 21–50 hours a month dealing with medicines shortages while 16% said they spent 51–75 hours; 5% were spending over 100 hours a month on medicines shortages.

 

Additionally, 48% of community pharmacists reported that patients had needed additional medical treatment, time off work or been caused emotional distress in the prior six months as a result of medicines being unavailable. And GPs reported the same outcome in 36% of cases where medicines were unavailable.

 

“We appreciate that the reasons behind shortages are complex and some are not always preventable, but this survey shows that those on the front line believe – like us – that a system which highlights early warning would help to limit the damage the current situation is causing,” adds Barron.

 

The survey was carried out in collaboration with North of England Commissioning Support between October 2015 and January 2016. There were 206 respondents, including GPs, practice managers, community pharmacists, primary care pharmacists, hospital doctors and hospital pharmacists.

Media Summary

APPG CHAIR ASKS BURT FOR MEETING OVER DRUGS SHORTAGES

9 June 2016, Pharmacy Biz, Neil Trainis

 

Pharmacy Biz reports that Sir Kevin Barron, chair of the All-Party Pharmacy Group, the APPG, has written to social care minister Alistair Burt requesting a meeting to discuss the ongoing issue of medicine shortages in the UK. Barron drew attention to a survey carried out by the APPG, which reveals that the problem of shortages has not been resolved yet. He added that: “the best action would be for the DH, NHS England and MHRA to work together to establish a system that accurately monitors medicines entering the supply chain, detects the shortage risks and helps supply chain participants alleviate the impact of shortages where they do occur”.

 

The full letter is available to read here.

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APPG CHAIR ASKS BURT FOR MEETING OVER DRUGS SHORTAGES

9 June 2016, Pharmacy Biz, Neil Trainis

 

Sir Kevin Barron, the chair of the All-Party Pharmacy Group, has written to the social care minister Alistair Burt asking to meet to discuss ways of solving the medicines shortage which continues to blight community pharmacy and endanger patients.

 

In his letter Barron (pictured) drew Burt’s attention to a survey carried out by the APPG revealing that the problem of shortages has far from been resolved despite the insistence of some in the pharmaceutical industry that the issue has been blown out of proportion.

 

Thomas Broeer, the vice-chair of the British Generic Manufacturers Association, told Pharmacy Business in 2014 when he chaired the organisation that generic drug shortages did not exist. During last year’s Avicenna conference in northern Cyprus, Sigma director Rajiv Shah insisted generic drug shortages cost independent pharmacists £10 million a year.

 

The APPG survey reinforced concerns that shortages remain a big problem, with 48% of community pharmacists surveyed saying shortages may have or did require patients receive “moderate medical treatment” when pharmacies were unable to dispense their prescribed medicine. Some 3% said this may have or did lead to a patient being hospitalised.

 

“Earlier this year, the All-Party Pharmacy Group and North of England Commissioning Support (NECS) conducted a survey to assess the impact medicine shortages have on NHS services and on patients,” Barron wrote.

 

“Those who participated in the survey were pharmacists in hospitals and in the community, and GPs and CCGs in the North East of England.

 

“Overall, it is clear from the survey that medicines shortages continue to occur. They cause inconvenience, stress and, on occasion, physical harm to patients. They cause disruption for health professionals and support staff, meaning that valuable NHS time is wasted on a regular and continuing basis.”

 

During the APPG survey 56% of community pharmacists said a medicine out of stock on a prescription presented at their pharmacy was “almost certain to occur” once a day and 36% said it was “likely to occur” once a week.

 

Forty-eight percent of community pharmacists also said they spent between 21 and 50 hours each month dealing with medicines shortages while 16% said they were spending 51 to 75 hours and 5% were spending over 100 hours.

 

“The survey asked for respondents’ views on the most helpful actions or solutions. Many felt that the best action would be for the DH, NHS England and MHRA to work together to establish a system that accurately monitors medicines entering the supply chain, detects the shortage risks and helps supply chain participants alleviate the impact of shortages where they do occur,” Barron wrote.

 

“I would welcome the opportunity for APPG officers to meet with you and representatives of the MHRA to discuss these findings in more detail and to consider actions that would improve the situation for patients and healthcare professionals.

 

“I hope we are agreed that GPs and pharmacists should spend their time diagnosing, treating and supporting patients rather than dealing with medicine shortages.”

Pharmacists in surgeries no ‘substitute’ for pharmacy ‘first contact’ role

Pharmacy Biz, Neil Trainis, 15 January 2016

A report by published by the UCL School of Pharmacy welcomes a three-year pilot scheme to place 400 pharmacists in 700 surgeries in a bid to reduce prescription errors and improve medicines’ use. However, it warns that it should beware of threatening the community pharmacy network and its patient-facing role.

 

Labour MP vows to draw attention to pharmacy funding cuts

Chemist and Druggist, Annabelle Collins, 14 January 2016

Kate Hoey, Labour MP for Vauxhall, vowed to mobilise political support to fight the announced pharmacy funding cuts. Ms Hoey stated that members of the health community should “speak out” to raise awareness amongst the general public.

 

PSNC demands clarity on NHS England’s long-term plans

PSNC, 15 January 2016

PSNC stated that it would not engage in negotiations with NHS England, until further detail of its longer term plans and the analysis underpinning them are made available. Sue Sharpe stated that she feared larger funding cuts and further efficiencies were planned for 2017/18.

 

Drug shortages in U.S. emergency rooms on the rise

Reuters, Madeline Kennedy, 15 January 2016

A recent study documented that medicine shortages in the United States had risen by 400% since 2008. The reason for half of the incidents was not found, while the rest is mostly blamed on systemic causes which underline the problem of a too low drug supply.

Parliamentary Coverage

House of Commons Question:  Prescription Drugs , 15 January 2016

 

Ms Margaret Ritchie, MP: What assessment he has made of the effectiveness of the processes undertaken by the NICE for approving and commissioning new medicines for cancers and ultra rare diseases; and if he will make a statement.

 

Department of Health

George Freeman, MP:

No such assessment has been made.

The National Institute for Health and Care Excellence (NICE) is the independent body that makes recommendations to the National Health Service on the use of selected drugs and treatments through its technology appraisal and highly specialised technologies programmes. NICE does not commission new medicines and treatments.

NICE is responsible for its own processes and methodology, which it periodically reviews in consultation with stakeholders. Further information on NICE’s processes is available at: http://www.nice.org.uk/article/pmg19/chapter/Foreword

The Accelerated Access Review, chaired by Sir Hugh Taylor, is looking at speeding up access to innovative medicines and technologies for patients. NICE has been working closely with the review as it develops its recommendations which are due to be published in Spring 2016.

 

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Pharmacists in surgeries no ‘substitute’ for pharmacy ‘first contact’ role

Pharmacy Biz, Neil Trainis, 15 January 2016

 

A report by UCL School of Pharmacy has warned that NHS England’s vision of putting pharmacists to work in GP surgeries is no “substitute” for their role as “first contact healthcare providers.”

NHS England’s decision to part-fund a three-year pilot scheme which will place over 400 pharmacists in 700 surgeries was, UCL said, “a valuable first step” in reducing prescription errors and improving patients’ use of medicines.

It did, however, caution that the initiative should not be seen as a replacement for pharmacy’s patient-facing role nor should it endanger the community pharmacy network.

That echoed concerns voiced by Ian Strachan, chairman of the National Pharmacy Association, who told Pharmacy Business last year that “to lose sight of the value of the current infrastructure, the system in which we work now and the huge potential that has within the existing frameworks of care, would be catastrophically short-sighted.”

The UCL report said: “There is a large body of evidence indicating that community pharmacy can play an extended part in delivering accessible health care, alongside roles like reducing prescription errors and facilitating better medicines use.

“Increasing the number of clinical pharmacists working in GP practices is a valuable step. But it cannot substitute for a clear vision for the future of community pharmacies as ‘first contact’ health care providers.”

The report added: “Without well planned, pro-active, interventions pharmacy skills will be under-used and the established community pharmacy network lost. Yet if each community pharmacy in England were able to take on just 10 per cent of the average general practice’s existing workload over the next five years, this will release approaching 5,000 GPs and similar volumes of practice staff for additional service provision.”

The report also called for an extension to pharmacist prescribing and an improved joined-up health records system instead of medicines home delivery services and hub and spoke dispensing.

“Some planners may wish to see savings made via concentrating dispensing in warehouse-like facilities and increasing the use of medicines home delivery services,” it said.

“Yet at a system-wide level a potentially more desirable way forward could be to extend pharmacist prescribing and improve shared health record systems. This would combine convenient local medicines supply with more accessible forms of ‘pharmacist first’ care in areas ranging from managing blood pressure to providing better chronic obstructive pulmonary disease (COPD) and type 2 diabetes prevention and care.”

 

PSNC demands clarity on NHS England’s long-term plans

PSNC, 15 January 2016

 

PSNC has today said that it is unable to commence negotiations on community pharmacy in 2016/17 until NHS England shares further detail of its longer term plans and the analysis underpinning them.

Responding to the letter published on 17th December 2015, in which NHS England announced a £170m funding cut and set out other plans for community pharmacy in 2016/17 and beyond, PSNC Chief Executive Sue Sharpe said she feared NHS England was aiming for a larger funding cut in 2017/18 alongside reductions in pharmacy numbers and a drive towards a commoditised supply service, bypassing access to the support and advice available at community pharmacies.

She said the Government was ‘ignoring entirely’ the evidence for the value of commissioning community pharmacy services, and that it appeared to have settled on a ‘course of action that will run counter to its stated ambition to develop a clinically focused pharmacy service’.

PSNC discussed the content of NHS England’s December 17th 2015 letter at its meeting this week (January 12th and 13th 2016). It had asked NHS England for information on its funding allocations for pharmacy for future years ahead of the meeting but this has not been forthcoming. Without this, and lacking further information on NHS England’s plans on pharmacy numbers and increasing the duration of prescriptions, the Committee felt it was being deprived of information essential for a proper consultation.

Read the full letter from Sue Sharpe below.

Community Pharmacy in 2016 2017 and beyond: Response from Sue Sharpe

PSNC will host a meeting of LPCs on 20th January 2016 to discuss its response to the Government plans and consultation and is also working collaboratively with the other national pharmacy organisations.

More information on the NHS England letter is available here.

 

Drug shortages in U.S. emergency rooms on the rise

Reuters, Madeline Kennedy, 15 January 2016

 

U.S. emergency rooms are increasingly running short on medications, including many that are needed for life-threatening conditions, a recent study documents.

Since 2008, the number of shortages has risen by more than 400 percent, researchers found. Half of all emergency room shortages were for life-saving drugs, and for one in 10 there were no available substitutes, they report in Academic Emergency Medicine.

Half of the individual shortage incidents had no explanation, the authors found. The rest had a variety of systemic causes that add up to a U.S. drug supply too low to meet public demand.

“Drug shortages are of particular concern in emergency care settings where providers must rapidly treat ill and injured patients,” said lead author Kristy Hawley of the George Washington University School of Medicine and Health Sciences in Washington, D.C. “For most medications, substitutes exist but may not be as effective and may have more side effects, or providers may not have as much experience with them,” she told Reuters Health by email.

The researchers looked at U.S. data on drug shortages between 2001 and 2014. The information came from hospital doctors’ reports, and it’s possible there were additional unreported shortages, the authors note.

The number of shortages declined steadily between 2001 and 2007 but began a sharp, continual rise in 2008.

Of the 1,798 shortages reported over the 13-year period, 610, or about one third, were for drugs used in emergency medicine. Over half of these were shortages of drugs used as lifesaving interventions or for high-risk conditions.

The average shortage duration for emergency drugs was nine months.

Drugs for treating infections were the most common ones to run low, with 148 shortages. Painkillers and drugs for treating overdoses and poisonings were also among the most common shortages.

Hawley noted that a particularly problematic shortage was for nalaxone, the only injectable treatment for opiate overdose.

In nearly half of shortage incidents, the manufacturer did not give a reason for the shortage when contacted. For shortages with a known reason, about a quarter were due to manufacturing problems or delays, around 15 percent were caused by market supply and demand issues and about 4 percent were from problems with raw materials.

“Just imagine that a critically ill patient comes to the ER and needs to have specific medication. When we do not have this medication, it can lead to delays in treatment, or it could lead to suboptimal treatment,” said Dr. Ali Pourmand, a professor of emergency medicine at George Washington University who was not involved in the new study.

Pourmand noted in an email that when doctors use substitute drugs they are less familiar with, there is a risk of medication error, and health care costs could increase as a result. Such errors could include issues with dosages or dangerous interactions between multiple drugs.

“Ultimately, a multifaceted approach involving regulators, manufacturers, providers, and other stakeholders will be required to address this growing public health problem,” Pourmand said.

In 2013, the U.S. Food and Drug Administration released a plan to combat drug shortages (see Reuters story of Oct. 31, 2013, here: reut.rs/1PelXlb). Last spring, the agency also released a mobile app for doctors and pharmacists to search for information about drug shortages.

Pourmand urges emergency departments to plan for shortages. “Current policy initiatives have had a limited effect on addressing drug shortages. Emergency Department providers must be aware of shortages and take an active role in mitigating their effects on patient care.”

“While local and regional systems can collaborate to prepare for shortages and put protocols in place to protect patients to the best of their ability, the root cause of drug shortages should be aggressively explored at the national level by policymakers, manufacturers, physician-led organizations, and patient advocacy groups,” Hawley said.

One in ten patients uses online services

DDA, Ailsa Colquhoun, 11 January 2016

Only 10% of patients report they use online services to order a repeat prescription, while 7% use it to book appointments and 1% to track their medical records. Charity Age UK warned against moving services online without adequate support for people who are not current users of Internet. Though awareness of available online services is better, consumers’ use has only increased very marginally.

 

Pharmacy bodies told to get behind petition to overturn funding cuts

Pharmacy Biz, 8 January 2016

The petition launched following the government’s announcement of funding cuts for pharmacy community has now received over 10,000 signatures, forcing the government to issue a response. Paul Mason, who instigated the petition, stated that patients and general public’s support was necessary to reach the 100,000 signatures with a deadline of the 29 June to put the question up for parliamentary debate.

 

Department of Health issues use of antiviral medicines letter

PSNC, 8 January 2016

The Department of Health (DH) has issued a letter advising that GPs and other prescribers working in primary care in England may now prescribe at NHS expense, antiviral medicines for the prophylaxis and treatment of influenza, in accordance with NICE guidance and the Selected List Scheme (SLS) in Part XVIIIB of the England and Wales Drug Tariff.

Community pharmacy contractors who receive NHS prescriptions – written generically or by brand –  for oseltamivir (Tamiflu) or zanamivir (Relenza), the antivirals included in the SLS list, are therefore reminded that prescriptions for these products must be endorsed ‘SLS’.  If the ‘SLS’ endorsement is missing, the prescription should not be dispensed and will not be passed for payment by NHS Prescription Services. Pharmacy staff cannot make the ‘SLS’ endorsement themselves.

PSNC would urge contractors not to over order stocks of antiviral medicines. Over ordering could result in shortages in the supply chain. It is, however, important that oseltamivir for adults and children and zanamivir for adults are taken within 48 hours of onset of symptoms. Children 5 years and over and under 13 years of age should start taking zanamivir within 36 hours of onset of symptoms, to obtain maximum benefit.

The DH letter also highlights the need to ensure maximum protection against flu through vaccination. Pharmacy teams are reminded to continue to encourage as many eligible patients as possible to get vaccinated against flu before the pharmacy flu vaccination service ends in February 2016.

 

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Full Coverage

One in ten patients uses online services

DDA, Ailsa Colquhoun, 11 January 2016

One in ten English patients (10.5%) has used online services in the past six months to order repeat prescriptions, according to the latest GP patient survey.

In addition only 7% of respondents have used online services to book appointments, and less than 1% of patients have used online services to access their medical records. Use of online services has shown only marginal increases since the previous patient research.

The survey shows that the majority of patients (87.2%) normally book their appointment over the phone, and over one in four (27.4%) book in person.

Charity Age UK has warned against moving public services online without providing sufficient support for those who are ‘offline’. It finds that around four out of five people aged 75 and over in the lowest socio-economic groups do not currently use the internet. It says: “Moving public services online without providing sufficient support … is making it harder for some pensioners to access vital services and could deter people from seeking the support they need.”

The 2015 GP patient survey in England shows that awareness of online services has increased, however. Nearly one in three patients (29.3%) are now aware they can book appointments online, an increase of 3.4 percentage points since 2014. A similar proportion (29.6%) are aware they can order repeat prescriptions online. There is much less awareness of online medical records, however.

Overall, the majority of patients (84.9%) rate their overall experience of their GP surgery as at least ‘good’. However, the proportion of patients who rate their experience as good continues to decline, albeit marginally since the previous survey in 2014.

Half of patients (50.4%) have a GP they prefer to see, a decrease of 3.1 percentage points since 2014. Of these patients, nearly three in five (59.0%) say they ‘always or almost always’ see them or see them ‘a lot of the time’, a decrease of 1.1 percentage point since 2014. Nearly one in five patients (19.2%) said that during the past six months they had wanted to access a GP during out of hours.

Over half of all patients (53.6%) have one or more long standing health condition (LSHC). Of these, 63% say they had enough support from local services or organisations to help them manage their condition, a decrease of 0.7 percentage points since 2014.

Rural GPs can compare their performance score against other CCGs using these online tools.

 

Pharmacy bodies told to get behind petition to overturn funding cuts

Pharmacy Biz, 8 January 2016

Paul Mason, the Barnsley LPC executive and man behind the petition attempting to force the government into a u-turn over its swingeing cuts to communuity pharmacy funding, has urged pharmacy bodies to back the campaign if it is to be presented to parliament.

The petition, which Mason launched on December 29, surpassed 10,000 signatures today, compelling the government to respond. The petition is, however, another 90,000 signatures away from taking the government’s £170 million reduction in pharmacy funding for 2016-17 to a parliamentary debate.

Mason said the only way the petition will attract 100,000 signatures is if patients and the general public support it. And with a June 29 deadline, time is not limitless.

That, he said, will only occur if national pharmacy representative bodies such as Pharmacy Voice and the National Pharmacy Association spread the petition’s message.

“The only way that’s going to happen is if patients and the public engage in it. There’s only so far we can go by engaging directly with people in the pharmacy profession. If we really have any hope of reaching 100,000 we’ve got to get patients in,” Mason said.

“How we engage patients and the wider general public, that’s a different question. There’s a limit for how social media can reach people.

“I’d like to see organisations promote it more widely. Our own national representational organisations, NPA, Pharmacy Voice, PSNC, RPS. I would like to think they would like to lend their support.”

When asked if pharmacy bodies had been slow to support the petition, he said: “Understandably. We did this over the new year. We’ve had some interest from some organisations but I’d like that to pick up.

“We need organisations to put messages out on mailing lists…to promote that outside of pharmacy, maybe posters, leaflets. There are many ways to get the message out. Time is of the essence.”

When asked if it was realistic to expect the government to reverse its decision on pharmacy funding cuts, Mason said: “The Department of Health and the Treasury have their own agenda. There are funding challenges in the NHS.

“I would like to see the government and the Treasury in particular look differently at how they can make savings rather than take 6% off the top. Pharmacy can deliver significant savings, possibly in excess of that, if it’s the right environment and contractual framework, to best utilise pharmacists’ skills.”

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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