Availability of raw ingredients including active pharmaceutical ingredient (API) shortages 7. “All of the issues we feared about Brexit remain. “This massive increase in supply failure is new, and the reasons for it need to be urgently identified and addressed to prevent inevitable harms to patients. Drug wholesalers are stockpiling medicines to create artificial shortages in order to drive up prices and forcing the NHS to pay more, according to a Mail on Sunday investigation. The document said that because there are shortages of many licensed medicines, in some cases unlicensed versions may be imported although “lead times vary”. The UK National Health Service (NHS) is experiencing severe medicine shortages of many lifesaving drugs, according to a document read and reported on by The Guardian. Increased demand 8. Medicine shortages are an everyday occurrence in the UK. The leaked document, from the Department of Health and Social Care (DHSC), listed dozens of medicine scarcities in the NHS, claims the report. The NHS is running short of dozens of lifesaving medicines including treatments for cancer, heart conditions and epilepsy, the Guardian has learned. Medicine Shortages can occur for many reasons including manufacturing and quality control problems, delays in supply chains and discontinuations. The document listed 17 new drug shortages identified last week including drugs for cancer, Parkinson’s, mental health problems and some eye conditions. A pharmacist making notes of the medication stock on the shelves in a pharmacy. The joint letter outlines preparations being made to enable the NHS to respond to and manage medicine shortages if the UK leaves the EU without a deal, as well as the support that will be given to prescribers and pharmacists. “The main supply routes for drugs have been through Europe, both in terms of red tape and logistics, as they’ve come from mainland Europe to the UK through ports. In April, NHS leaders anticipated a shortage of 4,000 beds for the winter. Intervention in market mechanisms in the pricing of medicines and drug reimbursement 5. Serious Shortages Protocols (SSPs) “As the virus becomes more prevalent again there is a real risk of a tsunami of cancelled operations unless surgical beds are funded and protected. Such shortages will have a high risk of harm to patients.”, Dr Tony O’Sullivan, a retired paediatrician and the co-chair of Keep Our NHS Public, said: “The Health Department’s guidance includes an unprecedented list of drugs unavailable or in short supply. Pharmacists spend hours tracking down stock and working together to help patients.”. Capacity issues 3. Latest figures show that there are now 106,000 vacancies across the NHS in England, including over 44,000 vacancies in nursing. “What we were relying upon in Brexit was a supplies stockpile. You may have seen the headlines about the shortages of medicines This problem of shortages is not a new issue If you are affected by a shortage, it is almost always possible to come up with an alternative Shortages are getting additional focus at the moment - uncertainties of Brexit etc - We can all… 90% of health leaders say that understaffing is putting patient safety and care at risk. The document stated that in some cases switching drugs would require increased clinical supervision, something which adds to the workload of already hard-pressed doctors. The college said hospitals had not begun providing 80% of normal services by the end of September, despite indication from NHS England that they should. Eight drugs have been discontinued and supply issues with over 20 drugs, where there were previous shortages, have now been resolved. Introduction: Over the last decade, global health policies and different research areas have focused on the relevance and impact of medicine shortages. Many are in serious pain, with their conditions deteriorating while they are on the list”, said Prof Neil Mortensen, the college’s president. This marks an increase from one year ago. Medicinal Product Shortages. Previously we would have one or two or three drugs that would go offline for a while, but this is something on a different level. Mann added: “The scale and scope of this list from DHSC of currently unavailable prescription medicines is extremely alarming. ... the NHS offers pharmacies a higher price concession rate designed to make up for the shortfall. The processes apply to all types of medicines used in the NHS, though additional processes for managing shortages may be required for vaccines, clinical trials, general sales list medicines and specials. That means building up theatre capacity and designating beds exclusively for those who need an operation”, he added. Tuberculosis medication: two suppliers are out of stock, a third has some stock “but is unable to support any uplift in demand”. None of those have gone away because we are in a pandemic. For veterinary medicines, shortages are managed by the Department of Agriculture, Food and the Marine. Medicine shortages - why are they worse and is it putting patients in danger? The document warned: “This information is confidential to the NHS, please do not upload to websites in the public domain.”. An RCSE survey of almost 1,000 surgeons found that only one in seven (14%) can treat the same number of patients as before the coronavirus crisis hit, with the maximum having fallen from four in a session to two or three, because of the need for social distancing, regular cleaning of operating theatres and the time it takes staff to put on personal protective equipment and take it off again. The call by the Royal College of Surgeons of England (RCSE) comes amid mounting concern about patients who are in the huge backlog of care that built up in the spring, when the NHS suspended many diagnostic and treatment services, especially surgery. Medicine shortages: A hard diagnosis. NHS Provider in England said Brexit could conjure ‘perfect storm’ of problems in winter, Last modified on Mon 5 Oct 2020 19.26 EDT. And on Monday, David Nicholson, the chief executive of NHS England until 2014, warned in the Health Service Journal that it would take hospitals years to get back to undertaking pre-pandemic numbers of operations. It also identified ongoing issues with 69 different types and doses of medication including antibiotics for tuberculosis, diamorphine, various cancer drugs, heart condition drugs, Hepatitis vaccines and anti-epilepsy drugs. Rachel Cooper, the director of the health initiative at the anti-corruption network Transparency International, said: “Shortages of medicines risk price distortion at the expense of health budgets, disrupt patient drug regimes and can undermine public health objectives. We need to think about what the stockpiles are looking like.”. Switching patients from one drug to another is not always straightforward or safe. It is going to render the day-to-day treatments that doctors provide very difficult.”, The report described one drug for stomach and pancreatic cancer which has no date for resupply provided by the manufacturer and “no alternative supplies of UK licensed [drugs] … are available to support this gap in supply. The NHS in Scotland can experience shortages of up to 80 medicines of varying impact at any one time unrelated to the exit from Europe. Patients and clinicians alike should be on high alert when the advice includes how to ‘share stocks’ to make them last, to ‘prioritise’ patients already on specific treatments including cancer rather than a new patient and effectively how to ration so many vital drugs. Hospitals across England are experiencing medicine shortages because of "stockpiling and price pressure as the Brexit deadline approaches", NHS Providers has told BBC Newsnight. The Medicine Shortage Response Group was established in January to provide guidance to the Department of Health and Social Care’s (DH) medicine supply team and NHS commercial medicines unit – which looks at medicine supply and procurement in hospitals – on “individual, critical” medicines supply issues, the DH told C+D earlier this month (April 5). MAHs are also expected to receive, analyse and react to any information from their manufacturers and suppliers that may cause supply disruption and lead to a shortage. Following concerns raised with us about medicine shortages, the CMA has sought information on the extent to which there are shortages of medicines in the UK and their likely causes. managing medicines shortages in the NHS in England. While shortages of some drugs have been reported previously, doctors have said that the breadth of conditions identified in the list obtained by the Guardian was “unprecedented”. A DHSC spokesperson said : “We hold a range of stockpiles for a variety of medicines, including crucial treatments used to treat Covid-19 patients to help ensure there is uninterrupted supply. You may wish to consider the following as a priority: patients completing a course of treatment and those already booked for surgery.”. Demand side Unexpected demand changes or fluctuations can lead to medicines shortages, and the risk increases with the use of just-in-time inventory control where Some treatments, like those for epilepsy, are not interchangeable. Drug Shortages This Document will be updated each month with the current information on medication shortages. Living with a chronic condition and being on treatment during COVID19:(File Photo) From the Eastern Cape to Limpopo, medicine shortages continue to be reported throughout South Africa. For a type of eye drops that are currently unavailable the document stated that the Royal College of Opthalmologists “has provided clinical guidance to support local prioritisation of remaining supplies”. Beyond Brexit stockpiling and manufacturing diversions, and parallel exporting, there appears to be a change in pharma companies’ behaviour causing a potentially dangerous level of instability in previously reliable, standard treatments. There is increasing evidence that a wide range of medicines are affected. The list features drugs for which the Department of Health has agreed to pay over the odds in order to prevent shortages. Dementia drug: need to change type and frequency of dose, which could be confusing for dementia patients. These additional processes are outside the scope of this document. Internal document seen by the Guardian shows low supplies for heart, cancer and anti-epilepsy drugs. Medicine shortages Updated: June 2020 Medicine (alphabetical order) Details Guidance Beclomethasone inhalers (Clenil brand) Problem: shortage of Clenil beclomethasone inhalers. If the Department of Health and Social Care (DHSC) decide there is a serious shortage of a specific medicine or appliance, then an SSP may be issued. Causes. Manufacturers know that any medicine shortage is extremely worrying for the people affected by it and they do everything they can to prevent medicine supply problems occurring and to resolve them quickly if they do happen.”, A spokeswoman for the Royal Pharmaceutical Society said: “Medicine shortages are an increasing problem. In some cases the document recommended breaking tablets in half, in others finding a way to share dwindling supplies. Distribution and logistical problems 9. It is thought this extra budget will only be able to provide 900 more beds, and thus there will still be long waiting times and unnecessary deaths. A range of factors are responsible for shortages, such as manufacturing problems, global demand for medicines and fluctuations in the exchange rate. British Medical Association Consultant workforce shortages and solutions: Now and in the future 3 The COVID-19 pandemic highlights the need to grow the consultant workforce NHS performance measures have been progressively deteriorating over recent years, with record low performance becoming a monthly norm over the past few winters. NHS Tayside is preparing for possible shortages of medicine, equipment and staff - warning that a no deal departure could "lead to an inability to deliver safe and effective care". The HPRA is responsible for co-ordinating the management of shortages of human medicines on the Irish market. For procyclidine, a Parkinson’s drug out of stock until March 2020, the document said that doctors should “consider sharing remaining stock locally with the support of your regional procurement lead”. Dr Nick Mann, a GP in Hackney in London, said: “This situation is absolutely unprecedented. The document told doctors that some patients would have to be prioritised over others for some lifesaving drugs, a form of drug rationing. Excessive par… Drug Shortages Prevention Plan, Risk-Based Approach for Prevention and Management of Drug Shortages) to reduce the risk of medicine shortages occurring. Manufacturing issues or disruption 2. Her remarks come after recent reports of a shortage of remdesivir, an antiviral which has been found to be effective in patients with Covid-19. Active ingredients for European products are made at 4420 sites in India, 2794 in China, 1936 in Europe, and 599 in the US.9 Medicines are cheaper to make in developing countries, but disruptions to infrastructure are more likely, distant factories are difficult to inspect frequently, and long supply chains are fragile. NHS staff shortages increase. “As part of our contingency plans we have also asked suppliers to stockpile at least six weeks’ worth of medicines, as part of a robust and flexible multi-layered approach which also includes re-routing supply chains and being ‘trader ready’.”. It’s important to remember drug supplies could be compromised”, said Saffron Cordery, the organisation’s deputy chief executive. Medicines shortages are a rapidly growing concern to the NHS in primary and acute care as well as globally. The public deserves full transparency of pricing structures and the reasons for and financial implications of drug shortages.”. Page 1 of 14 Medicines: Shortages and Supply Issues Supply Issues Update – as of 21st August 2020: The following advice is based on information available that the Cambridgeshire and Peterborough Medicines Optimisation Team were She added, “If we’re moving towards a no-deal exit on 31 October, without a transition period, the public, NHS staff, and the science and research community will all be looking for more information from the government about what this means.” The news comes after doctors in Scotland and Wales told The BMJ of ongoing medicine shortages. This is despite the announcement of an additional £145million to aid the NHS over the harsh winter. Brexit ‘already causing medicine shortages’ at pharmacies in England, One GP told the Guardian that the breadth of conditions identified in the drug shortages list was ‘unprecedented’ and represented a ‘high risk of harm to patients.’, shortages of some drugs have been reported previously. We know that supply issues can occur due to a range of unforeseen events and may be down to a combination of factors including: 1. She urged ministers to be open about drug shortages, to help NHS trusts prepare for them. Published studies suggest there have been difficulties with access to medicines since the beginning of the 20th century, and there have been advances in our understanding and management of the problem since then. Meanwhile, surgeons have called for some hospital beds to be reserved for patients awaiting planned operations even if a second surge of Covid disrupts normal services again. The causes of shortages are often complex. Diamorphine: “insufficient stock to cover full forecasted demand in both primary and secondary care”. Reason: increased demand affecting NHS supply chain. The Department of Health and Social Care declined to say if any of the drugs in the Brexit stockpile have already been used. I would suggest we have eaten into that stockpile because of Covid. Vaccine shortages 'will last months' as NHS staff face 'burnout' 01/01/2021. This could all change suddenly with a no-deal Brexit.”. Going into a second surge, securing respiratory drugs is a particular priority”, added Cordery. Cyanide poisoning drug: the sole supplier is experiencing long term out of stock issues. We must urgently protect the NHS from further risks of loss of control of drug prices and supplies from trade deals with the USA and that requires returning it to a wholly public service.”, A spokesman at the Association for the British Pharmaceutical Industry said: “For new on-patent medicines there is an agreement between the government and pharmaceutical companies to cap NHS spending growth on branded medicines at 2%, with anything over this paid back to the government. However the situation is likely to get worse for a time around the date of exit. Drug recalls and quality issues 6. The Medicines Shortages Response Group (Scotland) have developed priority definitions for shortage issues and potential responses depending on the severity of the impact of the supply issue, increasing in severity from a level 1 to a level 4 MSAN. In the case of Relpax, a migraine drug, which is in short supply, there was a recommendation to break the higher dose tablets in half although the document admitted “there are no data on halving or crushing them to deliver a 20mg dose”. Health union leaders have issued a stark warning that a no-deal Brexit could “devastate” the NHS and cause fatal medicine shortages arguing “no responsible government should take that risk”. Where a medicine supplied and/or administered under a PGD is subject to an interruption in supply a review of the PGD may be required. The DHSC has been approached for comment. Factors contributing to shortages A range of causes and contributing factors combine to create situations where the demand for a medicine is not met by adequate supply. “We saw problems with supplies during the first wave of Covid, for example of anaesthesia drugs because of high levels of ventilation. “Patients waiting for operations cannot be left behind indefinitely by the Covid crisis. 16th November 2015 | Laura Lopez Gonzalez. NHS Providers, which represents hospitals in England, said problems associated with Brexit could conjure a “perfect storm” of problems this winter that could undermine care, including flu, bad weather, workforce shortages, a resurgence of Covid and an epidemic of burnout among staff. Vaccine shortages ‘will last months’ as NHS staff face ‘burnout’ Vaccine shortages are likely to cause problems for ‘several months’, England’s chief medical officer has warned, amid fears staff at Covid ‘battlegrounds’ are at risk of ‘burnout’. Current situation: In order to help maintain supplies, additional batches of this inhaler are being released into the NHS Supply Chain. Mon 18 Nov 2019 01.00 EST 3,752 The NHS is running short of dozens of lifesaving medicines including treatments for cancer, heart conditions and epilepsy, the Guardian has learned. However … will be out of stock … until March 2020”. An MSAN provides information on the shortage of a specific item, or group of items. COVID-19 has The NHS has been working to encourage GPs to switch patients to generics in recent years in a bid to cut its prescribing bill. Vaccine shortages are likely to cause problems for ‘several months’, England’s chief medical officer has warned, amid fears staff at Covid ‘battlegrounds’ are at risk of ‘burnout’. 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