Is the opioid crisis coming to the UK and what impact could it have on medical negligence claims?

Opioids are natural and synthetic substances that activate opioid neuroreceptors in the central and peripheral nervous systems and include morphine, codeine, fentanyl, tramadol, methadone, oxycodone and hydrocodone (1–3). Despite a lack of evidence of their efficacy, they are frequently used to treat chronic pain (2). This condition is estimated to affect 20% of adults globally and is more prevalent in individuals of lower socio-economic status (SES) (2,4). Data from North America suggests that among those of lower SES, prescription opioid use is four times higher and death rates from opioid use increase as SES decreases (4).

Many countries have faced opioid epidemics in the past, but the current situation is particularly challenging as it involves both prescription and illegal substances (3). The crisis in the US, which has affected all age groups (5,6), has resulted from over-prescribing of opioid drugs for pain relief, leading to addiction, coupled with the availability of cheap pure heroin and the large-scale supply of illicit fentanyl and its analogues, due partly to the diversion of pain medication to those without prescriptions (1,5–8).

Prescription numbers peaked in 2010-12, at around 280 million (1) but have decreased since then (3). The prevalence of addiction in patients using opioids for chronic pain is around 3-16% in the general population but as high as 43% in some sub-populations (1,6). Due to increased regulation, prescriptions for opioids are harder to obtain, therefore addicted patients have been forced to turn to illicit markets. However, due to the cost of buying prescription opioids illegally, many have started to use heroin instead (1). Estimates for the number of deaths resulting from prescription opioid use vary, but there were thought to be over 40,000 deaths per year during 2015-7 (3,6), although other sources put the figure at less than half that (9). Drug overdoses are now the leading cause of accidental death in the US (1).

Although the total numbers are substantially lower, the UK has seen a similar trend in opioid consumption(2,3,8). In England, the number of opioid prescriptions rose year-on-year from 228 million in 1992 to 1.6 billion in 2009 (2), and in the UK as a whole the availability of analgesic opioids increased by nearly 70% between the periods 2011-13 and 2014- 16. However, this does not necessarily mean an increase in overall usage, as prescriptions might be for lower doses or smaller amounts at a time (3). Until recently, the rise in opioid availability was not accompanied by an increase in reported misuse or drug-related deaths (8), but figures compiled by the Organisation for Economic Co-operation and Development (OECD) show that between 2011 and 2016 opioid-related deaths in England and Wales increased from around 30 deaths per million population to 40 per million, a rate well above the 20% average across all OECD countries (3).

There are several reasons why the UK has not yet seen an opioid crisis on the same scale as the US. Firstly, there are fundamental differences in the healthcare systems of the two countries which may influence the relative harm of opioid misuse (2). In the UK, prescribing practice is for the lowest possible dose for the shortest possible time and it is difficult to obtain repeat prescriptions for opioids, although this clearly does not address access to illicit sources of these drugs (10). Furthermore, marketing practices by pharmaceutical companies in the US may have highlighted the benefits while downplaying the potential harm of prescription opioids (2) and have certainly played a significant role in escalating the problem. Manufacturers have also been implicated in some of the widespread opposition to the US Centres for Disease Control’s Guideline for Prescribing Opioids for Chronic Pain (3). Thus, in the UK measures such as the surveillance of marketing practices, prescribers, patients and overdoses may help to avert a public health crisis (8).

Clearly, the opioid crisis presents a challenge to those caring for patients with chronic pain. One measure which might help to reduce the potential impact of opioid dependency is for doctors prescribing opioids to use standardised tools to screen all patients for high risk behaviours, with additional monitoring and supervision being made available for those individuals identified as being at high risk of substance misuse. If a transgression is suspected, it should be discussed openly with the patient. (7,11). Consequential measures include limiting the dose and quantity of opioids prescribed, shortening the interval between follow-ups to allow for closer monitoring of the patient, stopping the use of opioid analgesics and referral to a pain or palliative drug addiction expert for co-management if necessary (11).

Doctors may also wish to explore alternative treatments, although effective substitutes for opioid analgesics are limited. Where the use of opioids is indicated, it has been suggested that extended-release opioids may be preferable compared to traditional release medications, as they are less addictive and are associated with lower rates of abuse (6). Other available analgesics include gabapentin and pregabalin, NSAIDS and antidepressants, particularly amitriptyline, but there is no clear and consistent evidence that any of these are successful therapies for chronic pain (2,3). In the future, calcium channel blockers, neurostimulation, gene therapy and transcranial magnetic stimulation may provide novel treatments for chronic pain (1). Furthermore, a multidisciplinary approach, which could include exercise, physiotherapy, massage and psychological therapies, may be useful for some patients (2–4,6,10). Unfortunately, patients’ access to these specialist clinics is often limited, partly as they are not universally available across the UK and waiting times may be substantial (2,10).

In order to assist health care providers, both the US and UK have published guidelines for those prescribing opioids (12). Public Health England (PHE) has funded the web-based initiative, Opioids Aware (3,13). This includes a section for patients which aims to allow them to make an informed decision about whether to begin treatment with opioids, as well as providing information on possible undesirable consequences (3). This initiative also emphasises the role of pharmacists, as well as doctors, in mitigating the adverse effects of opioid usage. Guidelines for the provision of over-the-counter analgesics containing codeine or dihydrocodeine state that these drugs should only be used for acute pain of short duration. Pharmacists are also encouraged to take a proactive approach by highlighting excessive or unusual doses and requesting a review by the primary prescriber (13). If adhered to, these guidelines should prevent a crisis on the scale seen in the US.

In the past 15 years, there have been over 1600 lawsuits, chiefly by city, state and county governments, against opioid manufacturers in the US (3,14,15) but to date, there have been few, if any, such cases in the UK. It has been suggested that the parties involved in these cases should reach a global settlement, similar to the one negotiated by tobacco companies in 1998, in which they agreed to fund educational and enforcement programmes and to recover tobacco-related health care costs over a 25-year period. However, there are several reasons why this situation may not be applicable to the opioid crisis. Firstly, opioid medications are beneficial in many people who suffer from severe pain. Furthermore, as opioids are not prescribed by the manufacturer, a company can discharge their duty to warn consumers of potentially harmful effects by informing a ‘learned intermediary’, such as a doctor, of any risks associated with the product. Finally, the defendants do not form a homogenous group as these cases have targeted various organisations associated with the manufacturing, distribution and sale of opioids, many of whom will have no direct intervention with patients. Thus, defendants may not see themselves as being equally responsible for the crisis (15) and establishing liability in these cases may be extremely complex.

In summary, while opioid availability has dramatically increased in recent years in the UK, we are yet to see a crisis on the scale of that in the US. This is probably due to differences between the two countries in the healthcare system and pharmaceutical companies’ marketing practices. Doctors may need to consider alternative treatments for chronic pain, although there are currently few really effective options. A recent initiative funded by PHE, which provides guidance for doctors, pharmacists and patients, should help to mitigate the potentially harmful effects of opioid analgesics. Although there have been numerous opioid-related lawsuits in the US, it is unlikely that a global agreement, in line with that reached with tobacco companies in the 1990s, will be negotiated for opioid analgesics, not least because of the difficulty of determining liability.

Dr Chris Jenner MB BS, FRCA FFPMRCA is a Consultant in Pain Medicine and leading expert witness in all cases which involve pain. Since 2001 he has been practicing at Imperial College NHS Trust as a Consultant at St Mary’s in Paddington, London and is an Honorary Clinical Lecturer for the Trust. He has a Pain Clinic at Charing Cross Hospital in London. Dr Jenner founded The London Pain Clinic in Harley Street London W1, where he is Clinical Director. He can be instructed through Medicolegal Partners Limited on 020 7118 0650 or info@medicolegal-partners.com. www.medicolegal-partners.

References

1. Morland R. Evolution of the national opioid crisis. Nursing (Lond). 2019 May;49(5):51–6.

2. British Medical Association. Chronic pain: supporting safer prescribing of analgesics. London: British Medical Association; 2017. 36 p.

3. Addressing Problematic Opioid Use in OECD Countries. OECD; 2019. (OECD Health Policy Studies).