Drug recalls and quality issues 6. 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. Causes. Drug Shortages Prevention Plan, Risk-Based Approach for Prevention and Management of Drug Shortages) to reduce the risk of medicine shortages occurring. A pharmacist making notes of the medication stock on the shelves in a pharmacy. The Department of Health and Social Care declined to say if any of the drugs in the Brexit stockpile have already been used. ... the NHS offers pharmacies a higher price concession rate designed to make up for the shortfall. NHS Provider in England said Brexit could conjure ‘perfect storm’ of problems in winter, Last modified on Mon 5 Oct 2020 19.26 EDT. 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. The causes of shortages are often complex. “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. These additional processes are outside the scope of this document. 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. The public deserves full transparency of pricing structures and the reasons for and financial implications of drug shortages.”. There is increasing evidence that a wide range of medicines are affected. The NHS is running short of dozens of lifesaving medicines including treatments for cancer, heart conditions and epilepsy, the Guardian has learned. “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. 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”. 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). 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. Reason: increased demand affecting NHS supply chain. 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. 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. A range of factors are responsible for shortages, such as manufacturing problems, global demand for medicines and fluctuations in the exchange rate. Medicinal Product Shortages. 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. 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. Drug Shortages This Document will be updated each month with the current information on medication shortages. Dr Nick Mann, a GP in Hackney in London, said: “This situation is absolutely unprecedented. Vaccine shortages 'will last months' as NHS staff face 'burnout' 01/01/2021. Latest figures show that there are now 106,000 vacancies across the NHS in England, including over 44,000 vacancies in nursing. Medicines shortages are a rapidly growing concern to the NHS in primary and acute care as well as globally. “What we were relying upon in Brexit was a supplies stockpile. Dementia drug: need to change type and frequency of dose, which could be confusing for dementia patients. 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. “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’.”. Anti-epilepsy drug: “Patients should normally be maintained on the same brand. 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. Current situation: In order to help maintain supplies, additional batches of this inhaler are being released into the NHS Supply Chain. You may wish to consider the following as a priority: patients completing a course of treatment and those already booked for surgery.”. 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”. 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. Excessive par… That means building up theatre capacity and designating beds exclusively for those who need an operation”, he added. Medicine shortages are an everyday occurrence in the UK. Commercial withdrawal 4. Hospitals across England are experiencing medicine shortages because of "stockpiling and price pressure as the Brexit deadline approaches", NHS Providers has told BBC Newsnight. 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. However the situation is likely to get worse for a time around the date of exit. 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. Pharmacists spend hours tracking down stock and working together to help patients.”. 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. An internal 24-page document circulated to some doctors last Friday from the medicine supply team at the Department of Health and Social Care (DHSC), headed “commercial-sensitive”, listed many drugs currently hit by shortages at the NHS. 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. 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. This could all change suddenly with a no-deal Brexit.”. “Patients waiting for operations cannot be left behind indefinitely by the Covid crisis. 16th November 2015 | Laura Lopez Gonzalez. 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. 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. For an optimal user experience we recommend that you use the most up to date version of your internet browser This marks an increase from one year ago. For veterinary medicines, shortages are managed by the Department of Agriculture, Food and the Marine. The DHSC has been approached for comment. “All of the issues we feared about Brexit remain. The document said that because there are shortages of many licensed medicines, in some cases unlicensed versions may be imported although “lead times vary”. Increased demand 8. 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. Introduction: Over the last decade, global health policies and different research areas have focused on the relevance and impact of medicine shortages. She urged ministers to be open about drug shortages, to help NHS trusts prepare for them. None of those have gone away because we are in a pandemic. 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. 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”. 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. Some treatments, like those for epilepsy, are not interchangeable. I would suggest we have eaten into that stockpile because of Covid. 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. “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. COVID-19 has 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. 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. The document warned: “This information is confidential to the NHS, please do not upload to websites in the public domain.”. Going into a second surge, securing respiratory drugs is a particular priority”, added Cordery. 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 The NHS has been working to encourage GPs to switch patients to generics in recent years in a bid to cut its prescribing bill. Tuberculosis medication: two suppliers are out of stock, a third has some stock “but is unable to support any uplift in demand”. Internal document seen by the Guardian shows low supplies for heart, cancer and anti-epilepsy drugs. The document listed 17 new drug shortages identified last week including drugs for cancer, Parkinson’s, mental health problems and some eye conditions. Switching patients from one drug to another is not always straightforward or safe. However … will be out of stock … until March 2020”. 90% of health leaders say that understaffing is putting patient safety and care at risk. Medicine shortages - why are they worse and is it putting patients in danger? 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”. 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’. Distribution and logistical problems 9. Eight drugs have been discontinued and supply issues with over 20 drugs, where there were previous shortages, have now been resolved. 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. Serious Shortages Protocols (SSPs) While some drugs for which there are shortages have alternatives which could be prescribed, others did not. Hospitals could face shortages of drugs during the second wave of Covid because some of the medicines stockpiled for Brexit have already been used, NHS bosses have warned. Many are in serious pain, with their conditions deteriorating while they are on the list”, said Prof Neil Mortensen, the college’s president. 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. Drug companies’ behaviour must be controlled. An MSAN provides information on the shortage of a specific item, or group of items. 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”. 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. The list features drugs for which the Department of Health has agreed to pay over the odds in order to prevent 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 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’. 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. 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. “We saw problems with supplies during the first wave of Covid, for example of anaesthesia drugs because of high levels of ventilation. 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. NHS staff shortages increase. Medicine Shortages can occur for many reasons including manufacturing and quality control problems, delays in supply chains and discontinuations. Cyanide poisoning drug: the sole supplier is experiencing long term out of stock issues. Mann added: “The scale and scope of this list from DHSC of currently unavailable prescription medicines is extremely alarming. Capacity issues 3. The document told doctors that some patients would have to be prioritised over others for some lifesaving drugs, a form of drug rationing. 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. 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. 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. At the moment pharmacists are working incredibly hard to get the medicines patients need. Availability of raw ingredients including active pharmaceutical ingredient (API) shortages 7. 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. In some cases the document recommended breaking tablets in half, in others finding a way to share dwindling supplies. Medicine shortages Updated: June 2020 Medicine (alphabetical order) Details Guidance Beclomethasone inhalers (Clenil brand) Problem: shortage of Clenil beclomethasone inhalers. It’s important to remember drug supplies could be compromised”, said Saffron Cordery, the organisation’s deputy chief executive. We need to think about what the stockpiles are looking like.”. 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. Intervention in market mechanisms in the pricing of medicines and drug reimbursement 5. 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". Diamorphine: “insufficient stock to cover full forecasted demand in both primary and secondary care”. 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… Mon 5 Oct 2020 19.01 EDT 1,106 Hospitals could face shortages of drugs during the second wave of Covid because some of the medicines stockpiled for … The HPRA is responsible for co-ordinating the management of shortages of human medicines on the Irish market. In April, NHS leaders anticipated a shortage of 4,000 beds for the winter. 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 leaked document, from the Department of Health and Social Care (DHSC), listed dozens of medicine scarcities in the NHS, claims the report. managing medicines shortages in the NHS in England. Manufacturing issues or disruption 2. 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. 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