Medication madness?

The widespread problem posed by chronic pain has helped fuel a dramatic increase in prescription opioid use. However, pharmacists can make a significant contribution to minimising harm from these drugs, according to a new review

Learning objectives

After reading this feature you should be able to:

• Explain the new NICE guidance on chronic pain
• Understand the role pharmacy teams can play in helping this patient group
• Encourage patients with chronic pain to consider ways to improve their quality of life other than with medication.

Key facts

• Chronic pain becomes more common with age and is often notoriously difficult to treat 
• The widespread problem posed by chronic pain has helped fuel a dramatic increase in prescription opioid use 
• A new review has found that all pharmacists in primary care can make a “significant contribution” to minimising harm from opioids.

The National Institute for Health and Care Excellence defines chronic pain as that which persists or recurs for more than three months. In its latest guidelines published in April, NICE differentiates primary from secondary chronic pain.

Chronic primary pain (CPP), it states, lacks an obvious cause, while in secondary chronic pain, an underlying condition (e.g. osteoarthritis, rheumatoid arthritis, ulcerative colitis or endometriosis) adequately explains the discomfort.¹

Chronic pain is often notoriously difficult to treat and this has helped drive the rise in opioid prescribing. While there is limited evidence of benefit for opioids^2,3 there is considerable evidence regarding the risks. Opioids, whether illicit or therapeutic, can cause numerous adverse events including altered mental status, falls, trauma, sleep disorders, hyperalgesia, endocrinopathies, depression and GI side-effects.²

Common problem

A meta-analysis of 19 studies has found that between 35.0 and 51.3 per cent of adults in the UK live in chronic pain.⁴ Their suffering takes many forms including chronic widespread pain (experienced by 14.2 per cent of adults), chronic neuropathic pain (8.2-8.9 per cent) and fibromyalgia (5.4 per cent).

Chronic pain becomes more common with age: prevalence rises from 14.3 per cent in people aged 18-25 years to 62.0 per cent in those 75 years and older.⁴ And as already mentioned, the widespread problem posed by chronic pain has helped fuel a dramatic increase in prescription opioid use.

Between 1998 and 2016, the number of opioid prescription items increased by 34 per cent from 568 to 761 per 1,000 of the population in England. Based on total oral morphine equivalency, prescribing more than doubled (127 per cent increase).³

The response to a particular analgesic dose depends on, among other factors, the person’s emotional responses.⁵ Emotional distress, particularly depression, typically co-exists alongside chronic pain, while stress often accompanies pain caused by inflammation or injury or both.⁵

The new NICE guidelines stress that healthcare professionals should consider this interrelationship between pain and psychology, and advocate developing care and support plans based on a “comprehensive person-centred assessment of the causes and effects of pain”.

Pharmacy teams could ask about, for example, the impact of pain on lifestyle and day-to-day activities as well as physical and psychological wellbeing. Other factors to consider include stressful life events (e.g. physical or emotional abuse), substance misuse and difficulties with employment, housing, income, social interactions and relationships.¹

Acceptance and commitment therapy for CPP should be considered, NICE suggests, as it seems to improve quality of life and sleep while alleviating pain and psychological distress.

In CPP, cognitive behavioural therapy (CBT) improves quality of life, but studies need to determine the effect on other outcomes. While there was insufficient evidence supporting relaxation therapy, mindfulness or psychotherapy to allow NICE to make recommendations, the guidelines note that “what evidence there was suggested there may be some benefit”.¹

Management approaches

A person’s strengths, such as pain management skills, should also be considered, says NICE, and he/she should be asked what they and significant others understand about, for instance, the causes of the pain.

Expectations of the condition’s trajectory and treatment outcomes should also be explored, and education, advice and support about, among other topics, self-management and the likelihood that symptoms will fluctuate should be offered.¹

Managing secondary chronic pain means optimising treatment of the underlying disease. Even if pain does not improve, management usually helps restore quality of life. Numerous studies report that exercise, for example, alleviates pain and improves quality of life compared with usual care in CPP.

NICE also suggests considering acupuncture or dry needling, within a traditional Chinese or Western system, which reduces pain and improves quality of life for up to three months compared with usual care or ‘sham’ acupuncture in CPP.¹

A meta-analysis of 31 studies involving 17,922 patients reported that acupuncture roughly halved the intensity of chronic pain caused by back, neck and shoulder problems, osteoarthritis and headache.⁶ Acupuncture’s benefits lasted up to six to 12 months.

The most common complications are bruising or bleeding where the needle is inserted and a transient vasovagal response,⁷ which can cause dizziness, visual disturbances and blackouts. NICE says that additional studies need to determine acupuncture’s longer-term benefits.¹

NICE suggests considering amitriptyline, citalopram, duloxetine, fluoxetine, paroxetine or sertraline for CPP patients aged 18 years and older (these are currently off-label for this use). It should be explained that antidepressants may improve quality of life, pain, sleep and psychological distress, even in people who have not been diagnosed with depression. The lack of head-to-head comparisons means involving patients in a “fully informed discussion” including risks and benefits.¹

For CPP patients aged 16 years and over NICE suggests avoiding several drugs including gabapentinoids, opioids and paracetamol (the guidelines include a full list). If CPP patients are taking any of these, healthcare professionals should explain the lack of evidence of their effectiveness. They can then agree a shared plan for continuing on treatment if patients report benefit at a safe dose and experience few harms.

Chronic pain patients could also be encouraged and supported to reduce and stop the medicine, including discussing any withdrawal syndrome.¹

Significant role

While GPs are responsible for most opioid prescribing, the authors of a recent paper were unable to find any systematic or scoping reviews assessing opioid management by pharmacists outside of hospitals.² This led Margaret Jordan, a general practice pharmacist in Woonona, New South Wales, Australia, and colleagues, to perform a scoping review that included 51 studies published between 2001 and December 2020. The review included studies where pharmacists were not involved in supplying medication.

Notably, studies enrolled people using opioids for chronic, non-cancer pain. Other studies included people with, for example, opioid use disorder, cancer or dental pain, and those receiving palliative care. Most studies of chronic, non-cancer pain assessed whether the pharmacist intervention reduced opioid doses.²

“Many of the studies were pilots or extensions of funding – which may explain why routine integration of pharmacists is sparse,” said Ms Jordan, who is also a PhD candidate at the School of Pharmacy, University of Sydney.

“The paucity of literature could be due to the imposts of recording outcomes in a formalised study that is then accepted for publication. We found abstracts presented at symposia where pharmacists are engaged in an amazing array of activities, so this scope of practice is definitely occurring.”

The studies took place in four broad settings: general practice or primary care clinics; healthcare organisations; community pharmacies; and outreach services. Pharmacists’ activities targeted risk mitigation, patient and provider education, and strategic approaches, such as policy and protocol implementation.²

Activities to reduce harm included lowering opioid load, avoiding opioid-sedative combinations, increasing uptake of take-home naloxone, assessing opioid-use disorder or adverse effects, enabling opioid agreements, urine screening and prescription monitoring.²

The review found that pharmacists in primary care can make a “significant contribution” to minimising harm from opioids. For instance, pharmacist-led services reduced opioid load, improved patients’ functionality and enhanced symptom management. In addition, pharmacists improved access to services and medicationassisted treatments, and patient engagement in risk mitigation strategies.

“Lowering the opioid load, especially in longterm use for chronic non-cancer pain, will reduce the risk of opioid-related harm. It is the simplest outcome to measure without the need for more sophisticated tools and validates pharmacists’ input,” Ms Jordan says. “However, reducing opioid load should not be the sole aim of an activity.”

A more holistic approach

NICE guidance recommending a more holistic approach to the assessment and management of chronic pain means pharmacy teams can be right at the heart of patient support, says Elaine Walker, senior brand manager for Deep Relief.

“For customers who are treating their chronic pain by taking paracetamol or oral OTC NSAIDs, pharmacy teams have an important role in helping them understand that NICE has concluded that there is a lack of evidence regarding efficacy, coupled with the risk of adverse effects. NICE also recommends that opioid use should not be initiated for chronic pain.

“Instead, exercise programmes and psychological therapies such as CBT and acupuncture are being promoted. Access to these therapies is patchy and while this is improving, there is a great opportunity for pharmacy teams to support patients by providing them with advice and information to help them understand their condition, make decisions and manage their expectations.

“Advising customers with chronic pain to take five to 10 minutes a few times a day to stretch as part of their normal routine can make a real difference to joint mobility and help to release areas of tension and pain.”

Pharmacy staff can also point customers in the direction of effective topical pain relief to improve outcomes, she adds.

Routine practice

“Community pharmacists have the opportunity to improve opioid management using methods that are accepted as routine pharmacy practice. Having the forum of a study provides explicit endorsement of the outcomes, but that does not minimise the role of pharmacists outside the boundaries of a trial,” she told PM.

“There are several harm minimisation strategies that can be recorded in the structure of a study, with most of these demonstrated in the scoping review. One such approach was to formalise a mechanism to recognise the person at risk of opioid-induced respiratory failure due to dose, concomitant medicines or comorbidities, and then providing counselling, supplying or implementing referral pathways for take-home naloxone. 

“In a pilot study described in the scoping review, a community pharmacy teamed with local prescribers. In this, the more detailed patient assessments of mood, pain and general activity were utilised, rather than opioid dose alone.

“An exciting Australian community pharmacy pilot8 that unfortunately did not make the scoping review included brief interventions delivered by pharmacists and the generation of GP referrals after universal screening for opioid use disorder and adverse effects in their patients dispensed opioids,” Ms Jordan adds.

“The message to funders and legislators is the essential role pharmacists have in opioid medication management and, crucially, patient safety. Larger, well-resourced organisations have recognised beneficial outcomes that can be extrapolated to smaller settings, with incentives.”

Often pharmacists were actively involved in patient management and received direct referrals or prescribed independently.² Importantly, Ms Jordan says, in many studies in the scoping review pharmacists did not have specialist roles in pain or opioid use disorder.

“The roles described in the management of opioids demonstrated pharmacists’ expertise in medication review and reconciliation, counselling, advising on therapeutic options, recognising those at risk of harm, and so on. These are recognised skills of all pharmacists, including those in the community.”

Opioid stewardship

The scoping review also showed that more collaboration and co-ordination could further improve outcomes,such as opioid stewardship.² “Based on antimicrobial stewardship, the model aims to avoid opioid adverse events in hospitals and reduce the risk of long-term opioid use by rationalising duration and supply at discharge,” Ms Jordan explains.

The programme could easily extend into the community.² Ms Jordan implemented opioid stewardship in a large general practice in New South Wales. “This was thanks to a grant from the local primary health network for a pilot study investigating the impact of a pharmacist on the management of high-risk medicines,” she says.

“The model was subsequently transferred to the practice management of benzodiazepines and ‘z-drugs’. The additional value identified in our pilot was in an embedded pharmacist providing medication reconciliation, review and therapeutic advice regarding all high-risk medicines, including gabapentinoids.”

Despite this success, several barriers may hinder pharmacists from realising their full potential in this field, says Ms Jordan – factors that community pharmacists in the UK will be very familiar with.

“Historical scopes of practice, such as the focus on supply, may be a barrier to overcome for many funders and those with the power to invest in new or varying models of care. The additional challenge comes from the demand to demonstrate cost-effectiveness so that investment in pharmacist services can be justified economically.

“I am always amazed that, despite evidence of benefit, pharmacists are not routinely the healthcare professionals sought out to manage medicines and the people for whom they are prescribed.”

The nightmare of drug dependence – Chantelle's story

Chantelle, a 35-year-old care company director found herself taking 400mg tramadol, 1000mg naproxen and 4000mg paracetamol “just to keep going”. The effect of all this strong medication was migraine-type headaches, bad sleep, constantly feeling tired — and she was still in pain.

Chantelle’s health problems started after being hospitalised with Covid-19 in April 2020. “I’d had a few problems with painful hips, but until I caught Covid-19 I was pretty healthy,” she says. “Once I had recovered, I was left in a lot of pain — all over my body. Over the next few months, I had all sorts of tests and eventually they diagnosed rheumatoid arthritis. That was a real shock. I was 35 years old, in terrible pain, a single parent with three children under 18 and I had a demanding job — I didn’t know how I was going to cope.”

Not surprisingly, Chantelle found life a real struggle. “My job involves a lot of driving to clients’ homes and physical work, and the arthritis had affected my hands, knees, feet, hips and shoulders. The pain was so bad. I could hardly walk and it took me an hour to get up every morning.

“I would come in from work and it was too painful to sit on the sofa, so I would go to bed. My older children had to cook dinner and do the things I had always done. I couldn’t clean the house or watch them play sport anymore – I couldn’t be the parent I had always been. It was difficult.”

Solution at hand

So Chantelle needed an analgesic cocktail to keep going but she still lived in considerable pain. “Things got so bad, I thought I would have to give up my job. Then in the summer, we went to Scotland for a holiday and I went to see my aunt, Bernadette Brown, a pharmacist in Glenrothes,” she recalls.

“[Bernadette] had started running pain clinics in her pharmacy and was having a lot of success using a bioelectric device from NuroKor. I was so defeated by the pain I didn’t think it would work but since using it each day I’ve been able to reduce my medication by over 80 per cent. It has made such a big difference to my life. I am sleeping again and the headaches have gone. My pain is now much more manageable and I am back to being a normal parent again.”

And finally – to cap it all...

Community pharmacist Shirin Mawji explains how the flip-top lid on Voltarol’s 12 Hour Joint Pain Relief Gel is transforming the lives of his patients by helping them manage their hand and joint pain more effectively:

“The new cap for Voltarol’s 12 Hour Joint Pain Relief (100g Gel) has been a total game changer for my patients who suffer from chronic hand and joint pain. They often experience debilitating pain in their hands, which limits their dexterity to the extent that they often can’t perform daily tasks such as tying shoelaces or opening food containers without experiencing pain when gripping or twisting.

“The main benefit of the new lid design is that it can be opened and closed in one simple action, removing the need for gripping or twisting. This means that opening with one hand or against a surface is easy. What’s more, the cap remains attached to the product tube — this is particularly useful for less mobile patients who would normally struggle to pick up a dropped screw cap.

“Patients have fed back that the new cap design is slicker, more appealing to use and, most importantly, has significantly improved the product experience for them, encouraging them to use the product more. We’ve seen a vast improvement in patients’ medication adherence as a result of this, which in turn which has improved the effectiveness of the gel at relieving their symptoms."

References

1. NICE: Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain
2. British Journal of Clinical Pharmacology 2021; DOI:10.1111/ bcp.14915
3. The Lancet Psychiatry 2019; 6:140-150
4. BMJ Open 2016; 6:DOI: 10.1136/bmjopen-2015-010364
5. Journal of International Medical Research 2020; 48: DOI: 10.1177/0300060520903653
6. Archives of Internal Medicine 2012; 172:1444-1453
7. BMJ 2017; 357:j1284
8. Research in Social and Administrative Pharmacy 2020; 16:1694-1701