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    The Battle of the Surcharge – won

    Finally, last Friday, the Government announced it was going to remove the surcharge that overseas NHS staff have to pay for using the service they themselves work for. This follows two years of campaigning by unions such as Unison and Unite, which between them represent over 600,000 nurses, student nurses, midwives, doctors, health visitors, healthcare assistants, paramedics, cleaners, porters, catering staff, medical secretaries, clerical and admin staff and scientific and technical staff, who are either employed by the NHS or by other organisations which provide NHS services.

    Only last Wednesday at Prime Minister’s Question Time Johnson told MPs that the extra raised £900m needed for the NHS. This has been challenged by the Institute of Fiscal Studies which put the sum at a tenth of that – £90 million. But that is irrelevant to this argument, which is that none of the overseas staff should ever have had to pay to use the NHS. The Government could focus instead on making all the big multinationals pay the taxes they avoid, just for a start.

    Unite national officer for health Colenzo Jarrett-Thorpe said: “Of all people, Boris Johnson should appreciate the wonderful and dedicated work of NHS health and social care professions, including the two non-UK nurses he singled out for particular praise in his fight for survival against coronavirus.

    Who is Dominic Cummings?

    He is not actually the Prime Minister, but appears to many to play the role of ventriloquist. He is not an MP or an elected representative of any kind. His official title is Senior Advisor to the Prime Minister, with an office in Downing Street. But he has succeeded in getting the British Public angry, which neither Boris Johnson, nor Matt Hancock, nor indeed any other member of the Government, has managed to do on anything like the same scale.

    What he has done was to behave as though the Government’s lockdown rules (which he proposed in the first place) did not apply to him, when many of us have not seen children, grandchildren and other loved ones for weeks, and too many have not even been able to say goodbye to those who were dying. And he is still refusing to admit to any wrong doing: “I think I behaved reasonably”. Up and down the country people are calling on him to resign – including more than 20 Tory MPs by Wednesday, 44 by Thursday morning with 61 criticising him. The numbers are still growing – and one Government minister has resigned over it.

    Cummings was responsible for the Brexit slogans “Get Brexit Done” and “Take Back Control”; for the campaign bus that said “We pay £350 million to the EU. Vote Leave and give it to the NHS instead” (which many of us knew was never going to happen, but some people were taken in by); for the offensive, enormous posters that said Turkey (population 75 million) was going to join the EU (implying 75 million Turkish people would be moving to Britain); and broke electoral law over spending limits, for which the campaign was fined £70,000. But not till the voting was over. The BBC website this week pointed out that Cummings was also held in contempt of Parliament for not responding to a summons to appear before, and give evidence to, the Culture, Media and Sport Select Committee. He also managed Johnson’s election campaign 2019, and is obviously very useful to the man who became Prime MInister, coming up with catchy slogans, launching a campaign against the Labour “heartlands” and advising Johnson how to handle public relations. David Cameron, a previous Tory PM, is widely quoted on twitter as saying Cummings was a “career sociopath”, while others have called him a narcissist on social media. As I am not a qualified psychiatrist I couldn’t possibly comment.

    Meanwhile a man called Craig Murray is a career diplomat, whose last job was as British Ambassador to Uzbekistan. He stood as an Independent in Blackburn in the 2005 General Election, opposing Jack Straw, then Foreign Secretary. And now he writes a blog in which he has drawn attention to Cummings’s presence in Castle Barnard on 12th April (allegedly testing his eyesight) which just so happens to be where the pharmaceutical giant, GlaxoSmithKline (GSK), has one of its 18 UK premises: an important research and manufacturing site. (See  https://www.craigmurray.org.uk/archves/2020/05/why-barnard-castle/ 24.05.20).

    Mary Wakefield, Cummings’s wife, who is editor of The Spectator,  published an article on 23rd April describing how ill Dominic had been for 10 days, with high fever, muscle spasms and difficult, shallow breathing. But on 5th April he was seen in his Father’s garden in Durham. On 12th April they were seen at Barnard Castle. On 14th April Cummings was back at work in London. On 14th April GlaxoSmithKline and Sanofi announced their collaborative agreement. On 19th April he was spotted again in Durham, though he has denied that he was there then. The former chancellor Sajid Javid was quoted in The Guardian (28.05.20) as saying the journey was not “necessary or justified”.

    Returning to Craig Murray, he further points out that GSK have been fined on more than one occasion for illegal behaviour eg fined £37.6 million in 2016 for bribing firms not to produce generic drugs. As a result the NHS would have had to pay more for these drugs, as generic drugs are cheaper than branded ones.

    GSK currently has 37 new medicines and 15 vaccines in development, according to its website. Its global HQ is in Brentford, Middlesex – you pass it if you drive into London on the M40, just before the turn-off for Kew. So a bit more handy for Cummings to get to from his own home, but also a bit more public. (GSK has 18 facilities in Britain and many more worldwide – offices, research labs and production facilities).

    On 14th April, 2 days after Dominic Cummings was seen in Barnard Castle, it was announced by GSK and the French firm Sanofi, which also makes vaccines, that they had signed a deal to develop and manufacture a Covid-19 vaccine. We all want that, don’t we? The long term solution to Covid-19 is a vaccine, just as measles, another viral illness that in the USA was serious enough for 48,000 people to need hospital treatment, resulted in 4-500 deaths and 1000 people developing encephalitis per year before the vaccination programme started in 1963.

    So why was Dominic Cummings not shouting about this development from the rooftops? It would, of course be illegal to use insider knowledge to buy up shares in the firms before their value on the stock market went up with the announcement of a potential vaccine for coronavirus. And indeed it might be a complete coincidence that he was nearby shortly before the announcement.

    Sanofi has developed an antigen based on recombinant DNA technology[1], which allows it to make a genetic match to proteins that occur on the surface of the coronavirus. They have called this the Spike (S) protein COVID-19 antigen[2]. The DNA sequence which encodes this antigen has been combined into the DNA of the baculovirus expression platform[3]. Sanofi has received some funding and collaboration from the US Biomedical Advanced Research and Development Authority (BARDA[4]).

    GSK will contribute its pandemic adjuvant (auxiliary) technology to the collaboration, so more vaccine doses can be produced. An adjuvant is used with the vaccine to stimulate the immune system, so that the vaccine is more efficient and longer lasting, and less of it is needed for each dose. This is an advantage when making enough vaccines to treat a pandemic.

    The firms have entered a Material Transfer Agreement to enable them to start working together immediately, with details to be firmed up in the following few weeks.

    BARDA’s website says its “mission is accomplished through successful public-private partnerships with industry to share risk, improve efficiency and accelerate development all while sustaining a marketplace that guarantees continued access to countermeasures vital to our national security.” “Our” here refers to the USA. It is not clear what advantage the USA intends to gain over the collaborative work of a British and a French firm, or whether Britain, France or indeed any other country with a serious outbreak of Covid-19, will be sharing in this.

    Cummings listed his goals as “Get Brexit done then Arpa” in a whatsapp profile mentioned on the BBC website on Monday. ARPA is the Advanced Research Projects Agency set up by the USA in 1958, which led to Silicon Valley. It is not clear what Cummings meant by this. It is clearly not a UK version of Silicon Valley – which has already been tried with variable longer term success eg in the science based firms around Cambridge, and in Silicon Glen in Scotland. But he might have in mind something like the US Cooperative Research and Development Agreement (CRADA), which was established in 1984 to encourage collaboration between firms and public sector research organisations or state agencies, and which has enabled firms to make money out of public sector research.

    An example of the CRADA was the anticancer drug taxol, or Taxol®[5], which has been very successful in treatment of ovarian, breast and other cancers, but for which patients must pay twice: first through their taxes which paid for the research supported by the National Cancer Institute and other public bodies, and second in the high prices charged for the drug, since the firm producing it (Bristol Myers Squibb, BMS) was allowed to charge a similar price to that of other anticancer drugs, which had not necessarily received public funding. Remember that in the USA patients will have to pay the cost of the drugs themselves or – if they have insurance – their insurance companies will; while the NHS will have to pay those prices for taxol imported here. There were three Congressional Hearings on this and related issues, but they did not lead to any difference in the legal status of the product or the property rights of the firm.

    Collaborative alliances have been a phenomenon in high tech industry, especially IT and biotechnology, since the early 1980s. Despite the risks of opportunistic behaviour by partners, the number of technologies and specialist fields in which firms need to keep up to date in order to innovate, has encouraged such relationships, though these have often ended in merger or acquisition, followed by new alliances in new specialisms.

    If a vaccine is successfully developed and prevents further outbreaks of flu-like conditions from this or other coronaviruses, and is available at an affordable price, then governments will consider any collaboration to have been a success. We have yet to see how the research will progress, and exactly what relationship the US government – which has contributed to the cost – or the UK or French governments – in whose countries GSK and Sanofi have their headquarters – will have to the firms in the collaborative alliance, let alone what benefit will accrue to people in other countries.

    From Vivien Walsh (Greater Manchester)

    [1] Recombinant DNA is what you get when segments of DNA from different sources are joined together. Recombinant technology = genetic engineering, which can be used to make eg human insulin, used to treat diabetes instead of the earlier treatment with insulin from cattle and pigs.

    [2] An antigen is a substance that can stimulate an immune response, ie activate the body’s infection-fighting white blood cells (lymphocytes).

    [3] A baculovirus is an insect virus. Recombinant baculoviruses can accommodate multiple “foreign” genes or large segments of “foreign” DNA. The baculovirus expression platform is used to generate recombinant proteins in insect cells at high production levels.

    [4] BARDA was established in the USA in 2006 during George W Bush’s Presidency. It is part of the Health and Human Services Office of the US Assistant Secretary for Preparedness and Response, which in turn was created the same year by the Pandemic and All Hazards Preparedness Act in the wake of Hurricane Katrina, to aid the USA in responding to chemical, biological, radiological and nuclear (CBRN) threats, to pandemic influenza (PI) and to emerging infectious diseases (EID). BARDA supports the transition of vaccines, drugs, and diagnostics from research to advanced development and consideration for approval by the Food and Drug Administration (FDA) and inclusion into the Strategic National Stockpile. BARDA’s support includes funding, technical assistance and core sevices, ranging from a clinical research organisation network to Centres for Innovation in Advanced Development and Manufacturing, and a fill-finish manufacturing network. To date, BARDA has supported 42 FDA approvals for products for products addressing CBRN, PI and EID threats. (From the various websites of the organisations mentioned)

    [5] Taxol was a natural product, extracted from the bark of taxus brevifolia, the Pacific Yew, which at the time could not be patented. It was developed by a huge network of researchers in the public sector and funded by US taxes plus the firm Bristol Myers Squibb, which manufactured and marketed it. To secure the intellectual property, BMS was allowed to trademark the name taxol in 1992, a name first given to the molecule by the chemist Monroe Wall in 1967, who first discovered its activity against cancer at the Research Triangle Institute in North Carolina.

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    US President Donald Trump has said he is taking hydroxychloroquine to ward off coronavirus, despite public health officials warning it may be unsafe.

    Please see this report from Simon Collins at HIV i-Base in the 14 May COVID-19 supplement to HTB (HIV Treatment Bulletin). Here is the report:

    Simon Collins, HIV i-Base

    Several studies have recently reported a lack of benefit from using hydroxychloroquine (HCQ) to treat COVID-19, with or without use of azithromycin (AZ). 

    These results challenge a controversial French study reported that an initial benefit that led to more than 100 new studies investigating this potential treatment, including some based in the UK, and despite higher risk of serious side effects.

    The first observational study, published in the NEJM, reported no association between HCQ and intubation or death in 1446 consecutive patients at a single centre in New York from 7 March to 8 April 2020, 70 were excluded due to intubation, death, or discharged within 24 hours.

    In the remaining 1376 patients, 811 (58.9%) received HCQ (600 mg twice on day 1, then 400 mg daily for a median of 5 days) during a median follow-up of 22.5 days.

    Just under half (45%) were treated within 24 hours of admission to ER and 86% within 48 hours. Participants receiving HCQ were more severely ill at baseline. Overall, 346 patients (25.1%) had a primary end-point event (180 patients were intubated, of whom 66 subsequently died, and 166 died without intubation). In the main analysis, there was no significant association between HCQ use and intubation or death (HR: 1.04, 95%CI: 0.82 to 1.32). A small percentage of patients also used tocilizumab or remdesivir. Results were similar in multiple sensitivity analyses.

    Given the observational design and the relatively wide confidence interval, the researchers concluded that their findings did not rule out either benefit or harm of HCQ treatment, but that they also did not support use of HCW outside of a research setting.

    The second report is a retrospective analysis of 368 patients hospitalised with COVID-19 in the US Veterans Affairs hospitals (n=97 HCQ; n=113 HCQ+AZ, n=113; n=158 no HCQ) and published ahead of peer review. [1]

    The two primary outcomes were death and the need for mechanical ventilation and results used propensity scores to calculate adjusted hazard ratios (adj HR) for clinical characteristics.

    Baseline characteristics included median age 70 years (youngest 59), 100% male and 66% black.

    Rates of death were 27.8%, 22.1%, 11.4% and ventilation were 13.3%, 6.9%, 14.1% in the HCQ, HCQ+AZ, and no HC groups, respectively.

    Compared to the no HCQ group, the risk of death from any cause was higher in participants using HCQ (adj. hazard ratio, 2.61; 95% CI: 1.10 to 6.17; p=0.03) but not in the HCQ+AZ group (adj. HR 1.14; 95% CI: 0.56 to 2.32; p=0.72).

    Also compared to the no HC group, the risk of ventilation was similar in participants using either HCQ (adj. HR, 1.43; 95% CI: 0.53 to 3.79; p=0.48) and HCQ+AZ group (ad. HR, 0.43; 95% CI: 0.16 to 1.12; p=0.09),

    These researchers emphasised the importance of results of prospective, randomised, controlled studies before general use of these drugs.

    A third study, ahead of review for Nature Research reported lack of effect from HCQ in vitro and also in macaques. [3]

    The abstract reports that HCQ showed antiviral activity in African green monkey kidney (VeroE6) cells but not in a model of reconstituted human airway epithelium. Also that in macaques, neither HCQ nor HCQ + azithromycin compared to placebo, showed a significant effect on the viral load levels in any of the tested compartments, including before and after peak viral load.

    No benefit was seen when HCQ was tested as a pre-exposure prophylaxis (PrEP).

    COMMENT

    Of note, none of these studies commented on the use of zinc supplement that is hypothesised to increase likelihood of benefit.

    Many comments posted online about the pre-peer review paper from Geleris et al emphasise the higher rate of hospitalisation in the HCQ group and the limited characteristics for many patients.

    The independent publication Prescrire also failed to find evidence of efficacy in its review of new data on HCQ, following several earlier articles cautioning positive data. [4]

    The FDA have issued a cautioned against the use of HCQ outside of clinical studies due to the risk of cardiovascular toxicity and that strongly recommends close supervision. [5]

     

    References

    1. Geleris J et al. Observational study of hydroxychloroquine in hospitalized patients with Covid-19. DOI: 10.1056/NEJMoa2012410. (7 May 2020).
      https://www.nejm.org/doi/full/10.1056/NEJMoa2012410
    2. MagagnoliJ et al. Outcomes of hydroxychloroquine usage in United States veterans hospitalized with Covid-19. DOI: 10.1101/2020.04.16.20065920. (23 April 2020).
      https://www.medrxiv.org/content/10.1101/2020.04.16.20065920v2
    3. Maisonnasse P et al. Hydroxychloroquine in the treatment and prophylaxis of SARS-CoV-2 infection in non- human primates. Nature Research. In Review. (6 May 2020).
      https://www.researchsquare.com/article/rs-27223/v1

    4. Prescrire. Covid-19 and hydroxychloroquine (Plaquenil): new data show no evidence of efficacy.
      https://english.prescrire.org/en/81/168/58639/0/NewsDetails.aspx

    5. FDA press releases. FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems. (24 April 2020).
      https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or

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    Treatments for COVID-19 could be manufactured for $1 a day or less, and distributed through mechanisms like those used for HIV, TB and malaria, reports Polly Clayden:

    First published by HIV i-Base in HTB (HIV Treatment Bulletin) on 14 April 2020.

    Polly Clayden, HIV i-Base

    If repurposed drugs, currently under investigation for COVID-19, show efficacy, they could be manufactured profitably at very low costs – according to an analysis published in the Journal of Virus Eradication
    on 8 April 2020. [1]

    As the SARS-CoV-2 pandemic grows daily, clinical trials are underway worldwide looking at potential ways to prevent new infections, treat those already infected and reduce the severity of the disease.

    Results from randomised controlled trials of repurposed drugs – ie those currently indicated for other diseases so shortening the drug discovery and development timeline – are expected between May and September of this year.

    Andrew Hill and colleagues – whose group have previously reliably predicted the minimum costs of drugs for hepatitis C and other diseases – calculated the costs of new potential treatments for COVID-19.

    The authors used established methods to make these calculations. They estimated the minimum costs of drug production by calculating the cost of active pharmaceutical ingredients (API), added to costs of excipients, formulation, packaging and a profit margin of 10%, to calculate the price of the final finished product (FFP) – the drug ready for use.

    The selected treatments were: remdesivir (previously used unsuccessfully against Ebola); favipiravir (influenza), lopinavir/ritonavir (HIV), chloroquine and hydroxychloroquine (malaria) and sofosbuvir and daclatasvir (HCV), azithromycin (pneumonia), and pirfenidone and tocilizumab (improve lung function and reduce inflammation).

    Remdesivir

    Remdesivir is given by IV infusion. A 10-day course of treatment is under investigation at a dose of 200 mg on the first day and 100 mg the following days.

    The authors estimated the cost per treatment to be approximately $9 per person – an estimated daily cost of $0.93.

    They note that costs for non-drug components associated with IV infusion were not included in this estimate:  saline, equipment (syringe, sterile water and IV lines) and staff time.

    Favipiravir

    Favipiravir is an oral treatment dosed at 600 mg twice daily. A 14-day course is being evaluated.

    The estimated cost of production for this course is $20 or $1.45 per day.

    The authors added that favipiravir was launched for sale in China in late February 2020 at a price of $231 per 14-day course.

    Lopinavir/ritonavir

    The standard dose of lopinavir/ritonavir is 400/100 mg oral combined pill twice daily. A 14-day course is also being evaluated.

    The estimated cost for this course is $4 or $0.28 per day.

    So far there has been no clear evidence of efficacy for lopinavir/ritonavir against COVID-19.

    Current list prices for a 14-day course range from $503 in the US to $15 in South Africa (and available through the Global Fund to low- middle-income countries for a medium of $9).

    Hydroxychloroquine and chloroquine

    These old malaria treatments (since the ’50s) were calculated at 400 mg and 155 mg daily doses for 14 days of hydroxychloroquine and chloroquine, respectively.

    The estimated costs were $1 per course or $0.08 per day and $0.3 or $0.08 per day for the respective drugs.

    Available list prices for a 14-day course of hydroxychloroquine ranged from $19 in China to $2 in India.

    For chloroquine these prices ranged from $93 in US to $0.2 in Bangladesh for a course. The authors note that the Bangladesh price was lower than their estimate and the US one might be considered an outlier (by a considerable amount as the next most expensive price for a 14-day course, in the UK, was $8).

    Azithromycin

    Used in small pilot studies with hydrochloroquine (and contradictory results) to prevent bacterial superinfection.

    A 14-day course at a dose of 500 mg per day was calculated at $1.40 or $0.10 per day.

    List prices for azithromycin range between $63 per 14-day course in the US and $5 in India and Bangladesh.

    Sofosbuvir/daclatasvir

    Under evaluation in Iran for people with moderate to severe COVID-19 symptoms at a daily dosage of sofosbuvir/daclatasvir 400/600 mg.

    The estimated cost is $5 per 14-day course or $0.39 per day.

    These drugs were launched by originator manufacturers for treatment of Hepatitis C at eye-watering prices, which have fallen significantly in recent years.

    Earlier estimates of minimum price for generic production by Hill et al in 2016 were equivalent to $7.8 per 14-day course, so the new estimates represent a 6.6-fold reduction since the group’s original calculations.

    Fourteen-day list prices range from $18,610 in the US and $7 in India or $6 in Pakistan.

    Pirfenidone

    A dose of 801 mg three times a day for four weeks is being evaluated.

    The estimated cost for a 4-week course is $31 or $1.09 per day.

    List prices for a 4-week course range from $9,606 in the US to $124 in Bangladesh and $100 in India for a generic version.

    The authors explained that at $100, the lowest list prices are still higher than their estimate.

    Tocilizumab

    This monoclonal antibody is dosed as an IV infusion. Doses are based on weight (8 mg/kg) with a maximum single dose of 800 mg every 12 hours.

    The authors assumed an average bodyweight of 70 kg and a single dose of 560 mg.

    There were no API data available for tocilizumab – so they were unable to estimate the minimum cost of production.

    List prices for 560 mg single dose varied from $3,383 in the US to $510 in Pakistan.

    Several biosimilars are currently under development but these have yet to be approved and launched.

    Biosimilars can offer healthcare systems the potential to lower costs significantly. The UK is expected to save up to £200–300 million a year through the uptake of better-value biological medicines.

    Conclusion

    The authors emphasised that we do not know yet which or any of these drugs will show benefit. But this analysis shows that if that was the case they all could be manufactured for very low prices.

    Repurposed drugs might be the only option to treat COVID-19 for the next 12–18 months, until effective vaccines can be developed and manufactured at scale.

    Some of the treatments are already available as generic, with prices close to the cost of manufacture for low- and middle-income countries.

    Treatments for HIV, TB and malaria are distributed worldwide by the Global Fund and PEPFAR at prices close the cost of manufacture. These prices allow generic companies to make acceptable profits. The authors recommend that a similar model of drug distribution be adopted for COVID-19.

    They made four recommendations to ensure that anyone with COVID-19, in any country, would be able to access the treatment they need:

    1. Treatments showing efficacy in well-powered clinical trials should be made available worldwide at prices close to the cost of manufacture.
    2. There should be parallel manufacture by at least three different companies for each product, sourcing their API from different countries. Production of drugs in a range of countries will protect us from disruption or shortages in individual countries.
    3. There should be no intellectual property barriers preventing mass production of these treatments worldwide. We need open ‘technology transfer’ so that the methods used to manufacture the key drugs can be shared with any country deciding to produce the drugs locally.
    4. Results and databases from all COVID-19 clinical trials should be fully accessible so others can learn from them. To speed up access to these drugs, countries could rely on recognition of the review and approval of key treatments by regulatory authorities in the US or Europe, or other stringent regulatory authorities. There may not be time for the normal times of regulatory review by all individual countries.

    COMMENT

    The authors looked at costs of production for the main treatments currently being tested in clinical trials.  These drugs could be mass produced for $1 per day, often for a lot less, and distributed through mechanisms like those used for HIV, TB and malaria.

    Even remdesivir, the new potential treatment from Gilead, could be mass produced for $9 for a 10-day treatment course.  The cost of the saline (and other non-drug components) would be higher than the remdesivir, when given by IV infusion.

    Some of these treatments have US list prices 100 times higher than the cost of production. The Presidential-favourite untested COVID-19 candidate is over 10 times as much in US as the UK. 

    Anyone with COVID-19, in any country, should be able to access these new treatments if the prices can be kept close to production costs. 

    Previous minimum cost estimates by Hill et al have been invaluable to support price negotiations for treatments for other diseases. Among many others, MSF welcomed the COVID-19 estimates. [2] “Literally every single person on earth is susceptible to this pandemic – now is not the time for price gouging and pandemic profiteering” they wrote.

    At the moment, countries are becoming insular, competing for limited supplies of drugs, ventilators and PPE, in bidding wars, rather than engaging in a collaborative system for resources to be prioritised for areas of greatest need.  

    References

    1. Hill et al. Minimum costs to manufacture new treatments for COVID-19. Journal of Virus Eradication. Online 9 April 2020.
      http://viruseradication.com/journal-details/Minimum_costs_to_manufacture_new_treatments_for_COVID-19/
    2. MSF press release. MSF response on COVID-19 drugs pricing study by Andrew Hill et al. 10 April 2020.
      https://msfaccess.org/pt-br/node/56576?tid=9
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    The pharmacists’ trade union, PDA, has called on all pharmacy employers to immediately adopt a “zero tolerance” approach towards abuse of pharmacists supported with clear statements to patients and 100% enforcement measures that make the safety of pharmacists and their teams a clear and consistent priority.

    The long running PDA campaign to end abuse and violence in pharmacies has recently gained significant prominence as incidents of abuse and violence experienced in pharmacies has increased during the COVID crisis. The campaign has now brought the issue to the attention of politicians, police forces and the general public.  ITV evening news and News at Ten on 9 April reported preliminary results of a PDA survey exposing the reality of abuse of pharmacists and their teams and the PDA are now sharing the final results after the survey finished on Easter Monday.

    PDA Director, Paul Day said “We know this isn’t all patients, nor the experience of a pharmacists every single day, but one incident of abuse or one assault is one too many and suggesting such behaviour can ever be excused creates an atmosphere that puts pharmacy teams at risk of further attacks. How can any pharmacy employer think that this could be acceptable? 

    The survey had more than 1,200 responses in less than a week and revealed the following key results:

    • In the past month more than 90% of respondents have seen incidents where patients/customers have behaved abusively or aggressively towards them or their colleagues.
    • More than 80% noticed that the number of abusive or aggressive incidents has increased in the past month compared to normal levels.

    The survey respondents reflected the scope of PDA membership with respondents from across the UK and across the profession. A majority of respondents from each sector of pharmacy had seen abuse, but those in community pharmacy had seen it significantly more frequently than others.

    The examples provided by respondents to the survey make disturbing reading generating a 40 page report detailing verbal abuse, intimidation, threats, racism, sexism and physical attacks. While the PDA believe decent employers would, and do, naturally want zero tolerance of such treatment of their employees the following two quotes suggest that some pharmacists experience what might be described as the opposite of zero tolerance:

    “Same man has made multiple pharmacy members cry. Was very aggressive and threatened me. Told xxxxx [the major pharmacy employer] about him and they did absolutely nothing. In fact, they offered him vouchers as he complained that we were rude. We literally have no support from anyone especially large multiples such as xxxxx who I work for who will do nothing about it.”

    “I did have a particularly nasty incident whilst working for a large multiple xxxxx . A male customer came in with an incompletely written CD prescription for a relative. It was a Sunday. I told him I couldn’t accept the prescription as it was incomplete and needed to contact the prescriber. This opened up a torrent of abuse. No support staff were nearby and there was no security and I was pregnant at the time. It made me feel very vulnerable. He told me he’d make sure I lost my job and hoped that I got cancer amongst all the f… words. I reported it to xxxxx on the Monday and they said he’d been in touch and threatened to give xxxxx bad publicity. They told me they sent him vouchers !”

    Mr Day concluded: “Any degree of abuse is unacceptable but it becomes even more worrying that we are aware of several very recent incidents that have involved physical attacks after which the police have been involved.  We made sure that the Assaults on Emergency Workers (Offences) Act 2018 carries greater penalties for attacking pharmacists, but our focus is on preventing attacks in the first place

    Being able to abuse pharmacy staff without consequences creates no deterrent for potential aggressors.   This cannot be allowed to continue and employers need to play their part. Introducing a genuine zero tolerance approach would be welcomed by employees and locums who all have a right to go to work without fear of abuse or attack”

    Last week the PDA called on the Company Chemists Association (CCA) to ask it’s members to adopt zero tolerance of abuse of pharmacists,   Read More.

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    One on International Trade dispute settlements and the other on Social Care.

    These are not official SHA policy.

    Issues for the NHS during UK Trade deal Negotiations

    As socialists we have an almost irreconcilable set of principles

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    Boris Johnson’s Queen’s speech includes this statement:

    “New laws will be taken forward to help implement the National Health Service’s Long Term Plan in England.”


    A Camden New Journal article ‘Beware false prophets’ published last month, reports:

    “The most alarming feature of the Long Term Plan, however, is that it completely locks in the contracts on offer through the adoption of Integrated Care Partnerships (ICPs).

    “These ICPs are the planned outcome of NHS England’s Sustainability Transformation Plans and Accountable Care Organisations, and are non-state organisations with a single management structure. Included within them are hospitals as well as primary and commun­ity care services – and possibly social care too.

    “These giant five to 10 year multi-million-pound commercial contracts will be open to bidding, and they will not be subject to public scrutiny (information is routinely withheld on grounds of commercial confidentiality). This will open the way to bids from giant international health corporations that already run similar de-skilling of healthcare in the US and elsewhere.”

     

    Jeremy Corbyn’s Labour speech in Northampton is clear:

    “For a decade our NHS has been run down, carved up, and prepared for privatisation. A Labour government will reverse this. We’ll repeal the Tory-Lib Dem privatisation Act of 2012. We’ll give our NHS the resources, equipment and staff it needs. That means more GPs and nurses and reduced waiting times. And under Labour prescriptions in England will be free.

    “And we’ll make life-saving medicines available to all by ensuring Big Pharma can no longer hold our NHS to ransom. The prices pharmaceutical companies demand don’t reflect the costs of the drugs they make. They simply charge as much as they can get away with.

    “We’ll use compulsory licensing to secure generic versions of patented medicines and create a publicly-owned generic drugs manufacturer to supply cheaper medicines to our NHS, saving our health service money and saving lives.

    “Only Labour can be trusted with the future of our NHS.”


    Please see Mariana Mazzucato’s The Value of Everything, especially Chapter 7 “Extracting Value through the Innovation Economy”. It explains value extraction by Big Pharma.

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    Tell us your views

    We are the regulator for pharmacists, pharmacy technicians and registered pharmacies in Great Britain. We set standards for pharmacy professionals.

    We are consulting on guidance for pharmacist prescribers which sets out the key areas they should consider when prescribing to ensure they provide safe and effective care. Pharmacist prescribers can diagnose conditions and prescribe medicines to patients. They often work in GP practices as well as in other healthcare settings, and can also work as part of an online prescribing service.

     

    Read our proposals and tell us your views now

     

    We want to understand the impact of these proposals on patients and the public. Help us spread the word by encouraging your members to take part. To help, we have a toolkit of materials which you can download from our website.

    We look forward to hearing your feedback.

    Best wishes

    Mark Voce
    Director of Education and Standards

     

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    The result of the historic ballot was 3,229 votes (92.4%) in favour of the trade union, with only 266 votes (7.6%) supporting the senior management proposal.  This also meant that 47.5% of those eligible to vote supported the union, which surpassed the 40% threshold required for the union to succeed.

    On the question of the ballot and what happens next at Boots, the union will now reach a recognition agreement with the company under the guidance of the Central Arbitration Committee.

    The PDA Union believe that the strength of feeling from pharmacists about the need to improve their employment is so strong at Boots that it was always inevitable that the union would win this ballot.  This overwhelming result simply demonstrates just how detached senior management  have become from the views of Boots pharmacists, over the last 8 years.

    Mark Pitt, Assistant General Secretary said: “We mustn’t forget that every single day over the last 8 years the company have had the ability to voluntarily recognise the PDAU, but every single day they decided to keep fighting their own employees.  As a result of this behaviour Boots will now be forced to recognise their employees’ choice of union.

    Despite the clear message from pharmacists in the 2018 ballot, where 87% voted in favour of removing the BPA to allow PDAU recognition, the company continued to use everything it could to stop pharmacists securing an independent voice at work until now. 

    Three senior managers became the faces of the 2019 management anti-union strategy; they risked their personal and professional credibility by running a negative campaign.  They not only lost, but this result shows support for the PDA Union has grown as this process has continued.”

    The PDAU hope that the company will now finally agree to put the past behind them and work positively together with the Union so that we can improve things at Boots for pharmacists, pre-registration pharmacists, patients and the company. John Murphy, General Secretary of the PDA Union has written to Boots head Seb James, inviting him to create a new, positive chapter in employee relations at the company.  Read more here,

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    The Pharmaceutical Journal reports that the Good Law Project threaten DHSC with legal challenge over “failure to consult properly”

    From The Pharmaceutical Journal 21 FEB 2019 By Carolyn Wickware:

    The Good Law Project has warned the Department of Health and Social Care that it will start judicial review proceedings if serious shortage protocol powers are not revoked on the grounds that the consultation was “insufficient and unlawful”.

    A non-profit group has threatened the government with legal action unless it revokes new powers designed to allow pharmacists to switch patients’ medicines if there is a shortage.

    The Good Law Project has said it will start judicial review proceedings over newly implemented “serious shortage protocol” powers if the Department of Health and Social Care (DHSC) fails to remove the amendments in legislation by 25 February 2019.

    Amendments to the Human Medicines Regulation 2012, which came into force on 9 February 2019, mean the government can now issue protocols asking pharmacists to respond to a medicines shortage in one of four ways: to dispense a reduced quantity, a therapeutic equivalent, a generic equivalent or an alternative dosage form of the drug.

    Under the protocol, the pharmacist would not have to consult the patient’s GP before making the switch.

    The Good Law Project is now seeking to launch a judicial review of the amendments, partially on the grounds that the government’s initial consultation – which lasted one week on 5–12 December 2018 – was “insufficient and unlawful”.

    In a legal document sent on 19 February 2019 from the group’s lawyers to the DHSC to inform them of their intent to start the review proceedings, the Good Law Project said it was “unclear exactly who the Secretary of State consulted with and how/on what basis”.

    It added: “The failure to consult properly with organisations representing specific patient interests was unlawful.”

    Ekklesia reports:

    Jolyon Maugham QC, Director of the Good Law Project, said: “Both doctors and patients have proper concerns about their safety in the event of medicine shortages. We want the Government to withdraw the prospect of SSPs [Serious Shortage Protocols] until it has complied with its legal duties and consulted properly on their use. If the Government does not take this step, the Good Law Project will launch judicial review proceedings in the High Court.”

    Professor Tamara Hervey, Specialist Adviser to Parliament’s Health and Social Care Committee, said: “In the event of a no-deal Brexit, there would be likely to be shortages of medicines. The absence of a legal framework for imports and exports drastically affects supply chains. Stockpiling plans cannot cope for more than a few weeks. This is a serious issue for people needing a regular supply of a particular type, strength and quality of medicine.”

    Jane Hanna, Chief Executive of SUDEP Action, who is supporting the judicial review said “Patients, doctors and pharmacists are used to prescriptions and the processes surrounding them. For people with long-term conditions, like epilepsy, what is on the prescription may represent months and years of trying out the best medication schedule. Changes made to this delicate balance can for some, undo this in an instant. For epilepsy this could lead to less seizure control, impacting on quality of life (ie: losing a driving licence, affecting home and work) and significantly for some this can prove fatal.  At present if a supply of medication is made in error, lessons can be learnt because of the clarity of who signed and who supplied the prescription.

    Deborah Gold, Chief Executive of NAT (National AIDS Trust) said: “We are deeply concerned that these changes were made without proper consultation. Prescribing HIV medication is a complex process which must take account of a multitude of factors. The only person qualified to safely alter the medication prescribed to a person living with HIV is that person’s HIV consultant.”

    • The Pre Action Protocol Letter can be seen here

     

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    Last year I told you about a group of 7,000 health professionals who had spent 7 years fighting for their trade union to be recognised by their employer. That campaign has now lasted 8 years. See: https://www.sochealth.co.uk/2018/05/05/solidarity-with-community-pharmacists/

    The Boots pharmacists were the first workers in any sector to challenge an employer through the ballot process described in that earlier article (above).  The law requires not just a majority, but that 40% of those eligible to vote, known as the “bargaining unit”, must vote “Yes” to make a difference.  The result was 87% of those who voted (2,826 pharmacists) voted Yes and that constituted 41% of the bargaining unit in favour.  This passed all the legal tests and the blocking agreement with the “sweetheart” union that the company was using to keep independent trade unions out, was ended by order of the Central Arbitration Committee.

    To emphasise what an achievement that is, if you measure the BREXIT referendum in similar percentages, of those eligible to vote it was just 37% vs 35%, so getting over 40% of eligible voters to support anything is no small achievement. Despite the clear result, the employer has continued to resist pharmacists’ efforts to secure an independent voice at work in the largest community pharmacy multiple chain.  However, in February 2019 the 7,000 pharmacists can vote again in a further postal ballot and this time it will force the employer to recognise the PDA Union

    One of the big issues for pharmacists is the company’s approach to performance management and the union have been hearing from pharmacists about what it means to them.  These quotes from pharmacists illustrate what the PDA Union are trying to fix so that these health professionals can get on with caring for patients.

    “In regards to its pay structure and market based pay it should be ashamed. It should be ashamed for its performance review where no person I have spoken to has any idea what it means to be above performing and where the pharmacy advisors, the people on the front lines get no bonus at all unless they are above performing.

    Nobody knows what exactly they need to do to be “above performing”. Even if you hit all your targets and are green on the scorecard despite those targets being an increase you are performing.”

     

    “I worked under this regime and it is a terrible way to work. The constant threat of a ‘non-performing’ rating is so demotivating and demoralising and it sometimes felt like a personality contest. I challenged it many times (probably another reason I would never win a corporate personality contest) and was told that even if all targets were met/exceeded you could still be classed as non performing so what’s the point!”

    Ballot papers will be mailed to pharmacists on Monday 18 February and completed ballots must be returned by noon on Monday 11 March in order to be counted.

    Boots directly employs well over 10% of all pharmacists in the country and has many more working occasionally as locums, so this is a significant story for pharmacy, but sadly under reported by the media.  Anyone interested in supporting the PDA Union and their members can help by spreading the word about this historic trade union campaign.

    The PDA Union was established in 2008, it is the only independent trade union in the UK which is exclusively for pharmacists.  It received a certificate of independence in 2010.  PDA Union is a member of Unions 21 and affiliated to the Employed Community Pharmacists in Europe (EPhEU) organisation and a member of Health Campaigns Together.  You can follow the PDA on Twitter, Facebook, Instagram and LinkedIN

    Written by Paul Day, National Officer at PDA Union.

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    Did you know there are a group of 7,000 UK health professionals whose employer has spent 7 years, and who knows how much money, preventing them from gaining an independent voice at work?

    What if I told you that part of this situation involves an entity, which is supposed to represent workers, that has signed an agreement with management committing to only “collective bargain” resources for their own officials and committing not to collective bargain for the employment terms of their members?

    This is what happened at Boots when the company signed an agreement with the “Boots Pharmacists Association” (BPA) in 2012 and in law this is enough to block an independent trade union, the PDA Union, from following the statutory process for recognition at that employer.

    The BPA is on the certification officer’s list of trade unions, but it is not independent. BPA was refused a certificate of independence in 2013. Part of the certification officer’s decision said: “looking at the picture as a whole that there emerges, in my judgement, a clear image of a union that has over the years been drawn into a situation in which it is indeed liable to interference by Boots… tending towards domination or control.”.

    Boots is the largest and most well-known community pharmacy business in the UK. The multi-billion pound global enterprise is a vertically integrated business profiting from both wholesale and retail sales of medicines, with much of that coming from the taxpayer via the NHS. The company has tried “everything” to block their employed pharmacists from getting independent representation and that includes the blocking agreement signed in secret with BPA at a time the company was simultaneously talking to PDA Union about statutory recognition.

    The good news is that the pharmacists have never given up and last summer six pharmacists, supported by PDA Union, applied to the Central Arbitration Committee to have the Boots-BPA agreement ended. Over 1,000 more employees pledged online to support the application, and after a further legal hearing at which the company and BPA’s joint attempt to give votes to senior managers (if they are a registered pharmacist) was overcome, a ballot is about to be held of almost 7,000 pharmacists working in Boots stores to end the blocking agreement.

    The law under which this ballot is happening has never been used before in any sector and the union must achieve 40% of those eligible to vote, to vote in support, hence their #2780pharmacists campaign hashtag.

    Ballot papers go out from 10 May and must be returned by 23 May in order to be counted. Anyone interested in supporting the PDA Union and their members can help by spreading the word about this historic trade union campaign.

    • Paul Day, National Officer, PDA Union @the_pda_union
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    Advanced paramedics in England will be able to prescribe medicines to people who do not need hospital treatment, under new laws starting on Sunday.

     Who will be able to prescribe?

    Advanced Paramedics  – those undertaking or having completed a Master’s-level (Level 7) qualification – will be allowed to complete a prescribing module, if their employed role has a need for it (i.e. you must be employed in a prescribing role, e.g. in a GP surgery. An AP cannot complete it if employed in a standard frontline paramedic role where prescribing is not a required qualification).

    How does this fit with other professions?

    Many other health professions can already prescribe. Nurses led the way, followed by various others including radiographers and chiropodists.

    Will this mean frontline paramedics will prescribe?

    No. To register, frontline paramedics have only completed a Bachelor’s-level qualification (Level 6) (from 2021), a Foundation level qualification (currently) or an in-work IHCD qualification (in the past), and therefore will not be able to apply for the prescribing module.

    Why are paramedics being given the ability to prescribe?

    Paramedics don’t just work in ambulances. We also work in GP surgeries, A&Es, walk-in centres, and Intensive Care Units across the country. Many of these roles are limited because the Advanced Paramedic, often employed alongside Advanced Nurses or other Advanded Allied Health Professionals, cannot prescribe, unlike their nurse & AHP counterparts. The change to the law will allow these to work equally to other professions, and will expand the number of range of jobs Paramedics can do (e.g. why employ an Advanced Paramedic who can’t prescribe, when you can employ an Advanced Nurse who can?).

    Will there be any prescribing in the Ambulance setting?

    Paramedic Prescribing is up to each Ambulance Service Trust to implement. There is certainly scope for benefiting the patient & the system if Advanced Paramedics are able to support frontline crews with prescribing skills. There are many cases where patients are taken to hospital or referred to the out-of-hours GP for a simple prescription that could, now, be handled by the ambulance service.

    Is prescribing just for non-emergency cases?

    No. Paramedic Prescribing will also widen the range of drugs paramedics are able to administer in an emergency when supported by an Advanced Paramedic. This too will be up to each Ambulance Service Trust to implement.

    Won’t people just call for an ambulance for a prescription because its quicker than waiting to see a GP?

    This question assumes that ambulances currently only go to emergency cases. This isn’t true, and we already attend many non-emergency cases that could/should be dealt with outside of the ambulance service. This has become the case through a combination of factors discussed in another article. Many of these patients, now they have entered an ambulance system ill-equipped and ill-trained to deal with their non-emergency health condition, are fed into the out of hours GP or hospital system.

    Giving the ambulance service the ability to prescribe will not reduce the amount of non-emergency cases we attend, but it will reduce the onward burden of these cases to other health systems.

    Furthermore, sometimes patients have multiple needs, some of which are urgent and some non-urgent, which may all contribute to an ambulance call-out. For example, a patient may have fallen and is unable to get up – a paramedic’s bread & butter – but the patient may also have an underlying chest infection or unmanaged chronic pain, which could have caused the fall.

    Say you’re wrong. What happens if calls for non-urgent cases do increase?

    The underlying issue here is that the Ambulance Services are already stretched between trying to provide quality care to both emergency and non-emergency groups. The concern highlighted in this question is that this tension may increase further if the patients begin to use the ambulance service in order to obtain a prescription quicker.

    The solution is not to stop ambulance services from prescribing in order to manage the tension, but to look at the systems that bring about the tension in the first place.

    Here I wrote how current ambulance services might overhaul the system by providing only emergency care, while another group of paramedics, either still employed by the ambulance service but with exclusive resources, or employed by new non-emergency ambulance services or by GP surgeries themselves, could handle non-emergency care.

    Paramedic Prescribing increases the ambulance services ability to provide 24 hour care in the community, independent of other services, across a whole range of acuities.

    This provides a potential solution to the increasing difficulty found by General Practitioners to be able to afford to conduct home visits and to provide out of hours care. Ambulance Services have held GP visits & OOH GP contracts in the past, and have delivered well. As long as we ensure that this doesn’t impact the emergency care delivery, ambulance services could reshape the landscape of care in the community.

    Where can I find out more?

    The College of Paramedics has led the campaign for paramedic prescribing, and has a lot of good information and documents on their website.

     

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