The National Essential Anaesthesia Drugs List

Drug shortages are common and are becoming increasingly so 1. Although shortages affect drugs used by all clinical specialties, anaesthesia is particularly vulnerable, not least because of its dependence on sterile injectable drugs with limited shelf-lives, rather than tablets with long shelf-lives. It is easy to define the three primary causes of a drug shortage: an increase in demand; a decrease in supply; or a combination of the two. However, within these three simple categories lie concealed many complex factors that range from the unavailability of an ingredient or technical failure of a manufacturing plant to difficulties complying with increasingly intricate regulatory standards, and commercial decisions related to the market for generic drugs 2. Even drug shortages can in themselves result in a shortage of other drugs when pharmacists and clinicians seek to acquire stocks of alternative drugs to those in impending low supply. Modern industrial theory such as ‘lean manufacturing’ has been held in part responsible for drug shortages 1, as have bodies such as NHS Improving Quality that, in its former incarnation, the NHS Institute for Innovation and Improvement, sought to label as ‘wastes’ the practices of overproduction ‘just in case’ and holding inventory because supply is unreliable 3. Governments have been slow to take notice of the risks associated with drug shortages, but some are now responding. The US Government's Drug Shortage Prevention Act 2012 places obligations upon the Secretary of Health and Human Services to advise the public, profession, wholesale distributors and manufacturers of the likelihood or occurrence of drug shortages, and to take steps to create a national contingency plan that addresses critical drug shortages 4. The UK Government's All-Party Pharmacy Group recently reported the results of its inquiry into medicines shortages, concluding that “shortages are being caused principally by the export of medicines intended for NHS patients to other EU countries” 5, although the report did proceed to offer practical recommendations about the introduction of legislation that would oblige wholesalers and pharmacies to maintain appropriate stock levels to minimise the chances of acute drug shortages. Drug shortages in Canada, and efforts by the Canadian Anesthesiologists’ Society to bring the issue of anaesthetic drug shortage to the attention of the public, profession and pharmaceutical industry, have led to the creation of a website that provides up-to-date information on shortages 6-8. The US Food and Drug Administration (FDA) has developed a strategic plan for preventing and mitigating drug shortages 9, and maintains a drug shortages webpage 10. When accessed for this editorial, the list of 72 drugs labelled by the FDA as ‘currently in shortage’ included preparations of atropine, bupivacaine, calcium gluconate, dexamethasone, ephedrine, adrenaline (epinephrine), fentanyl, ketorolac, lidocaine, magnesium, morphine, pancuronium, phentolamine and potassium chloride. On the same day, the European Medicines Agency's online drug shortages webpage itemised five drugs in ongoing shortage, none of which is routinely given in anaesthetic practice 11. The Medicines and Healthcare products Regulatory Authority (MHRA) does not provide online access to lists of drugs in shortages, and the English Department of Health has been under pressure from the profession and pharmaceutical industry to provide leadership over the issue of medicines shortages 2, 12. It is easy to assume that the consequences of shortages of drugs used in anaesthesia primarily revolve around an inability to deliver anaesthetic services and the subsequent cancellation of surgical procedures. This undoubtedly occurs, but is arguably not the main danger attributable to anaesthesia drug shortages. Surveys have reported that serious medication errors can result from drug shortages, resulting from a lack of familiarity with alternative agents, errors related to the use of different concentrations or sizes of ampoule, and the use of expired products 1, 13. Drug shortages raise the spectre of the use of single-patient drug containers for multiple patients to preserve drug stocks. In 2007, the use of 50-ml vials of propofol for multiple patients led to the transmission of hepatitis C to some patients and the exposure of another 40 000 patients to HIV, hepatitis B and hepatitis C 1. In a recent Canadian survey, drug shortages were reported as leading to an increased incidence of postoperative complications, most noticeably postoperative nausea and vomiting, prolonged recovery, patient complaints, litigation and even death 13. Drug shortages can undoubtedly have significant consequences for the safety of patient care. In an editorial published in this journal in December 2012, Ferguson and Woodcock challenged the specialty of anaesthesia to create a National Essential Medicines List for Anaesthesia and Peri-operative Care 2. They themselves took up this challenge and have been the key drivers behind the recent publication by the Association of Anaesthetists of Great Britain and Ireland (AAGBI) of NEADL – the acronymically much more satisfying National Essential Anaesthesia Drugs List 14. The list was created in an iterative process that allowed groups of experts and the wider membership of the AAGBI to contribute to its creation and to propose candidate drugs for the list. The NEADL identifies drugs that belong to one or more of three categories: essential; necessary; and critical. Drugs described as essential are those listed in the World Health Organization's 18th Edition of its list of essential medicines, i.e. drugs considered to be minimum medicine needs for a basic healthcare system 15. Necessary drugs are those used to treat or prevent a serious disease or medical condition for which there is no alternative medicine available in adequate supply, as defined by the US FDA 9. Critical drugs are those that are both necessary and vulnerable to shortage, as defined by the US Drug Shortage Prevention Act 2012 4. Further, NEADL offers alternative drugs that can be used in times of shortages and, importantly, suggests priority uses for drugs that have more than one clinical indication, the implication being that the drug be reserved for these uses in times of shortage, rather than in other areas where there are acceptable alternatives. Continuous surveillance, good communication and prospective local agreements between pharmacists and clinicians would be necessary to determine when actual or likely drug shortages hit an agreed stock or supply threshold to trigger restrictions on the use of certain drugs to priority indications. The NEADL also provides comments on the drugs listed, and both cautions associated with, and contraindications to, the alternative drugs suggested. Space does not allow a description of all the drugs in NEADL, but I will provide two brief examples to whet the appetites of those who have not yet accessed and read it. Propofol is termed both essential and critical, but not necessary, as shortages of propofol are not infrequent, and thiopental and etomidate are listed as alternative drugs. Its priority indications are the induction of general anaesthesia and sedation for critically ill patients whose lungs are being mechanically ventilated, whereas indications such as maintenance of general anaesthesia and sedation for short procedures such as reduction of dislocated joints are not identified as being a priority. The problems associated with the use of thiopental and etomidate such as extravasation and adrenal suppression are listed. Dantrolene is termed essential, necessary and critical, as there are no alternative drugs for the treatment of malignant hyperthermia and occasional supply problems have occurred. Clinicians will be keen to see if their favourite drugs are listed in NEADL. However, they should not be upset if their favourites are not included or not identified as being essential, necessary or critical – or even listed as alternative drugs. The list not prescriptive, and it is not set in stone – regular updates are planned. Indeed, there is an advantage to the use by some clinicians of drugs that are not listed as critical in NEADL, or not listed at all, as their use relieves pressure on NEADL drugs in times of shortage and retains skills and experience in the use of non-NEADL drugs. Some hospitals with highly specialised areas of clinical practice may wish to modify NEADL for their own purposes, adding or subtracting drugs, or identifying some drugs as being necessary for local practice, and others as being appropriate or inappropriate as alternatives for some groups of patients. This is entirely within the spirit of NEADL – it is a suggested list and is in no way meant to be universal or mandatory. The importance of the publication of NEADL is twofold. Firstly, it acts as a basis for local action by departments of anaesthesia. The latter should consider creating contingency plans for the shortage of essential drugs in anaesthetic practice, using NEADL to help identify alternative drugs, and setting priority uses in times of shortage. They might consider preparing guidance for drug use in times of shortage of NEADL drugs that can safely decrease waste, decrease use and, if necessary, decrease clinical activity while prioritising emergency care. They should work with hospital pharmacists to create stock levels of essential drugs that can act as a buffer against acute shortages, while taking into account shelf-life, storage costs and the volume of drug usage. With pharmacists, they should also prospectively consider which alternatives could be ordered when shortages occur. Secondly, NEADL should be used by the organisations that represent the specialty of anaesthesia to drive discussions with the UK and Irish Governments, the NHS and Ireland's Health and Safety Executive about what can be done to prevent drug shortages on a national scale and what support can be given to hospitals to mitigate the effects of drug shortages on patients and on the clinicians who care for them. Guidance from the UK Government published in 2013 entitled Best Practice for Ensuring the Efficient Supply and Distribution of Medicines to Patients begins with the sentence: “Patients can suffer distress and inconvenience if supplies of medicines are disrupted” 16. This substantially underestimates the risks to patients of drug shortages and highlights the need for pressure on governments and government agencies for a change in their approach. As Ferguson and Woodcock suggest in the editorial that launched the concept of NEADL 2, the solutions to anaesthetic drug shortages may include: better systems for reporting reduction in or discontinuation of manufacture, and making such reporting a legal obligation; effective communication systems to ensure that shortage information reaches those who need it; the mandatory stockpiling of essential drugs; and legislation to protect the supply chain of the drugs that we need to deliver safe and effective care to patients. The publication of the NEADL is the next step on a journey in which countries like the USA and Canada are already ahead of us. Clinicians and their professional leaders now need to take up the challenge and opportunity set by NEADL in order to address the important issue of anaesthetic drug shortage on local, regional and national levels. No external funding declared. I am the Immediate Past President of the AAGBI and an elected Council Member of the Royal College of Anaesthetists. The views expressed represent my own opinions and do not necessarily represent the policies of these organisations.

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