MHRA order stronger warnings for opioids


People who take prescribed or over-the-counter medicines containing opioids for non-cancer pain will now be given stronger warnings about the risk of dependence and addiction, the Medicines and Healthcare products Regulatory Agency (MHRA) announced.


Healthcare professionals have been asked by the MHRA to discuss these warnings with any patient taking or planning to take an opioid-containing medicine. These discussions should also involve the agreement of a treatment plan, including how long treatment should last, to minimize the risk of dependence.


Additional warnings are now to be added to the patient information leaflet to reinforce those warnings, making it clear that the medicine is an opioid, which can cause addiction, and that there can be withdrawal symptoms if people stop taking it suddenly.


Following concerns raised about the prescribing rates of opioids in the UK, the Opioid Expert Working Group (EWG) of the Commission on Human Medicines (CHM) developed a set of recommendations to improve information for prescribers and patients and to protect public health. These recommendations were fully supported by CHM and formed the basis of the MHRA’s new warnings.


While the CHM continues to consider opioids as important and effective medicines in the treatment of short-term pain relief, they have advised against their long-term use in the treatment of non-cancer pain, due to the risk of dependence and addiction.


Minister for Innovation Lord Bethell said:


“Opioid addiction is a serious and life-threatening issue and people need to be aware of these risks before they take medicines with such a high rate of dependency.


“It is vital that patients are given the right support and guidance on the dangers of long term use and the strengthening of these labels is a crucial step forwards in protecting patients and saving lives.”


The MHRA Director of Vigilance and Risk Management of Medicines, Sarah Branch said:


“Patient safety is our highest priority and that is why we continually monitor the benefits and risks of opioid medicines.


“Last year, we announced that opioid-containing medicine packaging must carry warnings. Now, we are strengthening those warnings to ensure that opioid medicines are supplied with consistent information on how to manage the risk of addiction.


“This is a further step forward in helping to promote the safe use of these pain-relieving medicines.”


This circular is being shared under the Open Government Copyright licence.



I think my prescription opioids could have killed me


I have lived with persistent pain almost all of my life starting with ‘growing pains’ as a child, which sadly, did not leave me as I got older. This series of blogs describes my journey from dependence on opioids to control my pain to an opioid-free life.


My name is Louise Trewern and I am 52 years old. I have 4 grown-up children and am married to a wonderful woman called Karen who for many years was my full-time carer.


I have fibromyalgia which wasn’t diagnosed until my mid-thirties and arthritis in my knees and feet. I was sickly as a child and suffered from repeated chest infections that would have me missing school. Whilst there, I was unable to participate in sports. A the time I was told I had bronchitis, a diagnosis later disputed when as an adult I had chest x-rays which threw doubt on this.


The pain was my constant unwelcome companion as I entered my working life.


It was extremely difficult to cope with, especially as I always felt that my colleagues doubted the legitimacy of my pain experience; this meant I got quite depressed over time. I lived with the myriad of symptoms associated with fibromyalgia, chronic fatigue, widespread pain, various infections, stiffness, poor sleep, depression, irritable bowel etc.


Gradually my pain worsened. I developed a bad back that would “lock-up” overnight and this would mean that I could not get out of bed quickly enough to look after my children.


I was eventually referred to the pain service and given opioid medication which initially was marvellous. Suddenly, I was able to continue looking after my family and working part-time.


Over the following years, the dose of opioids needed increasing to retain efficacy and although I did not realise it, I was beginning to experience the awful side effects of long term opioid use, skin infections, noise sensitivity, gut problems, more frequent colds, which for me would last longer than my friends and family and completely knock me off my feet. I believed the side effects were my fibromyalgia worsening.


Many of the side effects required treating with yet another prescription medication.


I was hospitalised several times with unexplained severe pain, often in my chest, which was quite scary. Eventually, I had to give up work, I was unable to cope at all due to the awful fatigue coupled with debilitating pain.


Gradually my hospital file got thicker and thicker with all the specialities I was visiting for ‘this test and that’ which almost always were returned with inconclusive or negative results. This also had a detrimental effect on my mental health. The anxiety when the doctor says ‘you might have ‘X’ condition we will send you for a test’, then weeks or often months later, receiving the negative results.


I became so bad that I would hardly leave the house and hated taking telephone calls even from my family. I could not tolerate any noise in the house, and it would even hurt when the cat walked across my lap. I was unable to make any plans because I never knew how I would be from one day to the next.


Babysitting my grandchildren became out of the question unless Karen was with me. I didn’t trust myself not to fall asleep and my self-confidence was at zero. I didn’t feel capable of looking after them.


My weight had increased to 25 stone despite my best efforts to lose weight which I now realise was never going to happen because I was not active, I wasn’t sleeping, and I was on a cocktail of medications.


The point came when my opioids needed increasing again.


I was referred to the Pain Service where I met a wonderful CNS. She began to talk to me about the possibility of reducing my opioids and over several appointments taught me some strategies to cope with my flare-ups of pain. During this time, I suffered my first emergency admission to hospital for opioid-induced impaction.


I ended up in theatre for surgical intervention. A few months later I suffered a second and this was the final straw. The theatre staff told me this was a common occurrence for them with people on opioids. This horrified me, especially as I was taking Macrogol sachets twice a day to prevent this.


I decided I wanted to come off the opioids altogether, no matter how hard that would be, and I firmly believed that if I did not, they would kill me.


Louise Trewern is a patient advocate who has devoted much of her spare time to explaining her lived experience being on and coming off high dose opioids. She is also a passionate walker for pain relief.


A film was made of my experience by the team at Live Well With Pain Website. You can access it by clicking here.




Should over-the-counter opioid sales be banned in the UK?


As pharmacy professionals, it is our duty of care to ensure that patients receive treatment suited to their needs, in order to provide optimal benefit. An issue that is well known in pharmacy practice is that of over-the-counter pain relief. These consultations can be difficult as it is often hard to determine whether the patient is receiving the correct drug and dose for their pain and that there are no underlying dependency issues.


To address this issue, the student-led Pharmacy Law and Ethics Group at Robert Gordon University held a debate in March this year with the title:


“Is it in the patient’s best interests to ban the sale of OTC opioids to reduce addiction and harm?”.


The debate was led by Annamarie McGregor from the Royal Pharmaceutical Society who gave an unbiased background on the issue of OTC opioid dependence. There is a current estimate that 3-28% of patients on chronic opioid therapy have opioid analgesic independence (OAD), which can stem from predominant comorbidities such as mental health issues and a history of substance misuse. (5) Whilst OAD is a threat to public health, as professionals, we must be aware that pain must still be managed by the use of appropriate treatment. (4) By understanding the balance between benefit and risk of opioid prescribing, patients can be treated with the confidence that their medication will not lead to dependence or adverse events.


Following Annamarie’s introduction, two pharmacy student speakers from the University argued for or against the debate title. Ewan Hardie, a fourth-year student, gave an opposing view and touched on mortality with regards to prescription-only opioids. He explained that deaths involving opioids appear to occur more frequently in those taking prescribed opioids in comparison to OTC users. (3) He also discussed that the majority of OTC opioid users are infrequently purchasing products like co-codamol for short term pain relief. It is these patients who would be impacted by an OTC opioid ban, unable to self-manage ailments whilst adhering to the guidance given by their community pharmacy. (3) Ewan explained that these patients would require to see a GP, impacting on the NHS and increasing their waiting time for acute pain management.


Secondly, Vivien Yu, a second-year student, argued for the debate title. Vivien compared the UK’s current OTC codeine sales to Australia, who banned OTC codeine on the 1st of February 2018 due to research showing low-dose codeine-containing products offered little additional pain relief to non-opioid analgesics. (2) She also explained that by making OTC opioids prescription only, patients would require to have a sit-down conversation with a healthcare professional to ensure that the treatment was the most appropriate for their pain management. (1)


Overall, the debate offered in-depth insight into both the benefits and the risks of prescription and OTC opioid use. A motion was passed involving opinions of those attending the debate. The motion was as follows: “The RGU Pharmacy Law and Ethics Group believe that better safeguarding should be in place with regards to OTC opioid sales, rather than proposing an outright ban. A Pharmacy First approach should be adopted for acute and chronic pain management”. This motion was agreed on as, after a full discussion, it was decided that OTC opioids are required for short-term use to manage acute pain. However, it was suggested that a more in-depth consultation through community pharmacies would benefit patients, ensuring that their pain management is tailored to their needs to reduce the risks of adverse effects and dependence.


Katie Waghorn is a 4th Year MPharm RGU, PLE Group Leader 18/19.


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[1] ANDALO, D., 2016. Survey of UK public reveals extent of over-the-counter drug misuse and abuse. [online] London: The Pharmaceutical Journal. Available from: here [Accessed May 15th 2019]

[2] KLEIN, A., 2017. Australia bans non-prescription codeine to fight opioid crisis. [online] London: New Scientist. Available from: here [Accessed May 15th 2019]

[3] KOLODNY, A. et al., 2015. The Prescription Opioid and Heroin Crisis: A Public Health Approach to an Epidemic of Addiction. The Annual Review of Public Health, 36, pp. 559-74

[4] LYAPUSTINA, G. and ALEXANDER, C., 2015. The prescription opioid addiction and abuse epidemic: How it happened and what we can do about it. [online] London: The Pharmaceutical Journal. Available from: here [Accessed May 14th 2019]

[5] SHAPIRO, H., 2015. Opioid painkiller dependency (OPD): An overview. London: DrugWise.