New boxed warnings for pregabalin and gabapentin give pharmacists the opportunity to discuss pain management with patients.
The Therapeutic Goods Administration (TGA) announced on 1 February that medicines containing pregabalin and gabapentin will now come with boxed warnings in the Product and Consumer Medicine Information (CMI), following an investigation of ongoing misuse of pregabalin, and abuse of and dependence on both pregabalin and gabapentin.
In its investigation, the TGA cited data from the National Coronial Information System, which found that pregabalin-related deaths have increased exponentially, rising from 16 in 2013 to 121 in 2016. Most of these deaths were unintentional.
The warnings will serve as a guide for health professionals to screen for abuse or misuse, as well as inform patients about the risks associated with use.
Impact on patients
According to Jarrod McMaugh MPS, PSA Senior Pharmacist, Consulting and past President of Chronic Pain Australia, the boxed warnings may have a particular impact on patients who inadvertently overuse pregabalin and gabapentin.
‘Patients who are not achieving adequate pain relief may be less likely to take an extra dose when they are made aware of the black box warning,’ he said.
Despite this benefit, Mr McMaugh said some prescribers may be over cautious and see the warnings as a reason to reduce the supply of these medicines.
‘There is a risk that patients might suddenly lose access to these medicines, or they might decide to cease or reduce their use of pregabalin or gabapentin of their own accord,’ Mr McMaugh told Australian Pharmacist.
‘But as long as healthcare professionals review their patients adequately and provide a treatment plan around ceasing use, then it shouldn’t be a problem.
‘It would also be useful if gabapentin and pregabalin were included in Real Time Prescription Monitoring (RTPM) programs to ensure that people at increased risk of overuse can be identified and assisted early on,’ he said.
Both gabapentin and pregabalin will be incorporated in some jurisdictions’ RTPM systems, including Queensland’s QScript, which should roll out later this year.
Mr McMaugh said the CMI provides pharmacists with an opportunity to discuss patients’ treatment with pregabalin and gabapentin, particularly those who have just commenced use.
‘Pharmacists should inform patients that gabapentinoids are quite potent and they do have some risks associated with them,’ he said.
‘But it’s important to ensure that message is delivered appropriately without alarming the patient, which could lead to cessation.’
If patients do exhibit increased anxiety, pharmacists should reassure them that medicines prescribed for the correct indication are safe, but carry risks.
‘It’s very much about allaying a patient’s unnecessary fears and putting any concerns they have into perspective,’ Mr McMaugh said.
‘Pharmacists should balance the realistic harms that a patient could be exposed to against the benefits of treatment and the harms of stopping suddenly.
‘It’s a matter of taking each person’s case individually, and understanding what their risks are and what they are hoping to gain from treatment without lecturing them.’
If a patient is still hesitant, pharmacists should refer them to their prescriber to discuss a treatment plan for tapering to reduce any side effects associated with sudden cessation.
Efficacy of treatment
Nicolette Ellis MPS, Senior Clinical Pharmacist for Beyond Pain, said pharmacists should be acutely aware that increased use of pregabalin or gabapentin does not necessarily mean the patient has a substance use disorder.
Many patients who live with chronic pain may increase their dose with the expectation that the medicine will improve their pain experience, so it’s important to start the conversation with open-ended questions, such as inquiring about how the pain might be impacting their day-to-day life or what they find beneficial about the medicine for their pain.
‘Gabapentinoids have many side effects including weight gain, peripheral edema, low mood, cognitive decline and sedation which can pose a significant barrier to improving an individual’s function, psychosocial abilities and quality of life,’ Ms Ellis told AP.
‘Up to 50% of patients taking gabapentinoids will experience adverse effects and identification of these medicine-related harms tends to be under-recognised. It’s essential that when we are having these conversations we are also screening for these symptoms.’
Ms Ellis also emphasised the importance of talking to patients about the purpose of taking a medicine for chronic pain, which is to improve their function and quality of life.
‘There should be a measurable goal in mind when patients start or continue a medicine for persistent pain, such as being able to walk for 20 minutes daily in the next 1–2 months,’ she said.
Ms Ellis suggested pharmacists offer the use of validated tools to measure the benefits of their treatment, which should be selected based on the purpose of use, such as to improve their function, sleep or mood. These tools include:
Gabapentinoids have been increasingly prescribed as the “non-opioid alternative” for all types of chronic pain, including non-neuropathic conditions such as non-specific lower back pain, fibromyalgia and osteoarthritis, despite there being little or no evidence for their use to treat these conditions.
But even in the treatment of neuropathic pain, Ms Ellis said, gabapentinoids should be prescribed and dispensed judiciously, as much of the trial evidence is limited to those who live with post-herpetic neuralgia or diabetic peripheral neuropathy.
Guidelines also recommend that patients on long-term therapy should attempt to challenge the efficacy and dose of therapy on an annual basis.
‘The benefits and risks of gabapentinoids can be a lot to unpack, and I would encourage pharmacists to use services such as a MedsCheck or Home Medicines Review,’ Ms Ellis, said.
‘Pharmacists should feel confident to discuss medicine risks and how to manage them, particularly when there is concomitant prescribing with other high-risk medicines.’
Evidence indicates that there may be up to a 49% increase in the risk of opioid overdose when combined with gabapentinoids.
‘If a pharmacist believes a patient is at risk of overdose, they should confidently discuss their concerns with the prescriber and ascertain how this risk is being managed,’ Ms Ellis said.
‘If there is no plan, pharmacists need to take a supportive approach and recommend harm minimisation strategies, such as staged supply, dose administration aids, gradual tapering plans and naloxone therapy, if combined with opioids.’
Collaborating with allied health professionals
When it comes to seeking expert care to manage their pain, Ms Ellis said it’s all about helping patients find their “A team”.
‘It’s not necessarily about having all the different types of healthcare professionals to treat their condition, it’s about having the right ones, who can coach and guide patients in the self-management of their condition,’ she said.
‘That might be a physiotherapist, an exercise physiologist or a psychologist – it really depends on the individual, their goals and their needs.’
One of the most important resources for pharmacists searching for allied health professionals with experience in chronic pain is Primary Health Networks, she said, but pharmacists can also do their own research.
‘Talk to these healthcare professionals about their experience in treating persistent pain patients,’ Ms Ellis said.
‘When looking for other allied health professionals to recommend, have a look at their experience online. Many who specialise in chronic pain will list their work experience.’
Ms Ellis pointed out that pharmacists likely see chronic pain patients more than any other healthcare professional, so they should be well informed.
‘It’s important that we can both triage and be there to support the GP, the patient and all of the other health professionals involved in treating chronic pain,’ she said.