While the tightening of opioid rules might bring pain and panic, for patients and healthcare professionals alike, there’s hope for a positive outcome
Over the past decade there has been increasing concern regarding the harms associated with long-term use of prescription opioids. Indeed, in 2018, opioids accounted for three deaths per day. While the bulk of opioid-related harms were accidental overdoses, the number of unintentional drug-induced deaths involving opioids has more than trebled in the last 10 years.
To address this problem the TGA has made a number of regulatory changes, which are supported by the Pharmaceutical Benefits Scheme (PBS). The changes, which came into effect on June 1, see opioid medications available in smaller quantities with no repeats for the treatment of non-chronic pain, as well as new eligibility requirements.
Some opioid listings will now be Authority Required. This means pharmacists will need to ensure any relevant dispensed scripts have a valid streamlined authority code. Pharmacists are also now required to make certain prescribers have correctly requested increased quantities or repeats for chronic pain through telephone/electronic authority for up to one month’s treatment or electronic/written authority for up to three months treatment.
Explaining the transition
“Opioids are not evidenced based for chronic pain, which means we shouldn’t be starting someone on opioids for chronic pain today. If you have the opportunity to reduce anyone, it’s important to work with the patient safely, gently and respectfully to do so,” says Joyce McSwan, pharmacist and founder of professional service program PainWise.
“The intention is coming from a good place in terms of risk reduction and patient safety. But when there’s no major warning, and these changes came into play very quickly, that evokes a different emotion. Rather than seeing a proactive effort you get a reactive move. People panic and messages get construed.
“Indeed, the problem is inherent; there are patients who are already stuck in the cycle, their bodies have adapted to need opioids. You can’t change this situation in a hurry; because it didn’t take a day for them to be opioid dependent, it took years.
“Of course, these PBS changes are trying to get people in good practice in general. However, it affects operations on a day-to-day level and yet there are no additional services to support primary health practitioners.
“In some cases, what a person was paying for a month’s supply of opioids they now have to pay for a week’s supply. If people can’t get the medicine on the PBS it’ll lead to forced withdrawal.
“People are panicked, so they might not be as open as we might like to talk about alternative ways to manage their pain. Patient discussion needs to be sensitive and respectful; it needs to reduce panic by providing lots of reassurance.
“We can explain that we are transitioning and the reality is that it might cost patients a little bit more in the long run, but suggest we explore the possibilities of an alternative treatment,” Ms McSwan says.
Pharmacist’s confidence in opioid interventions
The Routine Opioid Outcome Monitoring in Pharmacy study was completed in August last year. It involved a computer-facilitated screening and brief intervention to support pharmacists to identify opioid-related problems.20
It was led by Associate Professor Suzanne Nielsen, deputy director of the Monash Addiction Research Centre at Monash University, Melbourne.
A/Prof Nielsen explains, “We were trying to introduce a relatively low level intervention that any pharmacist could administer without additional training.
“The validated routine opioid outcome monitoring (ROOM) tool was embedded into the pharmacy’s software, so the pharmacists didn’t need to ask the questions in a specific way. Scoring was also automated through the software, so there was no training required in this area.
“The software produced a tailored information sheet for the customers based on their screening score. It also produced a customised letter for their prescription provider, which detailed the scores and what information the pharmacist had provided.
“The key role for the pharmacist was essentially to reinforce the information on the sheet provided by the software and answer any questions the patient might have.
“This study wasn’t attempting to extend the role of the pharmacist scope of practice, but more so to facilitating them to perform these types of interventions,” explains A/Prof Nielsen.
Despite pharmacists already being heavily engaged in the supply of prescription opioids, she says their knowledge and confidence at baseline before the training was relatively low.
“When asked about managing events such as low-level dependency on opioids, pharmacists self-rating revealed a score of 1.8 out of 4 for their confidence to respond to these types of issues in the pharmacy. This shows low levels of self-assurance in these areas.
“Following the training, pharmacists’ knowledge and confidence levels increased only slightly. What the study identified is that there is real scope to further leverage training and to help pharmacists feel consistently confident in this area.”
The wrong words
One of the problems is that many of the tools that are typically used to screen for opioid use disorder are developed around illicit opioid problems, A/Prof Nielsen says, meaning the language and wording are not appropriate for a pharmacy setting.
“As part of this study, we have developed, validated and published a four-question screening tool that can be used in pharmacy. There’s also the Routine Opioid Outcomes Monitoring (ROOM) Tool, which is a more holistic 12-question tool that looks at outcomes with opioids—including analgesia activity, addiction and side effects.”
With regards to the recent PBS changes, she says this provides pharmacists with the opportunity to talk to patients about opioid use and the potential risks.
“Pharmacists need to feel confident that they have something to offer in order to start the conversation. Our secondary analysis from the implementation study found that pharmacists who had low knowledge of naloxone and lower confidence in identifying unmanaged pain in patients on opioids were less likely to perform interventions.
“So it does seem that having effective ways to build pharmacists’ confidence to have these conversations might empower pharmacists to feel in a better position to be able to use some of these screening tools available to them.
“Certainly, we know from many years of research that when clinicians don’t feel confident to respond to a problem that a screening tool might identify, they are less likely to screen. No one wants to find a problem that they don’t know how to solve.”
Collaboration at the coalface
“People living with chronic pain struggle with limited access to treatment and support options resulting in doctors and consumers continuing to rely heavily on prescription opioids to manage what is a multi-faceted, complex condition that needs more sophisticated responses,” says Painaustralia CEO Carol Bennett.
Despite attempts to raise awareness and reduce the number of opioid-related adverse events, Ms Bennett says more needs to be done.
“We need better awareness among consumers and doctors about pain management treatment options—and we need to ensure those options exist. Where pain medication is prescribed, people living with pain will also benefit from a multidisciplinary approach to their care,” she says.
Ms McSwan adds, “The fact is we are really limited when it comes to evidence-based alternatives to pain management. Not everyone will be able to tolerate other medicines; there is the possibility of side effects and limited success rates.
“Therefore, it might not be about a drug alternative, but instead a very comprehensive planning alternative incorporating the physiotherapist, the exercise physiologist and increased patient education. However, these are not so easy to fund.
“To solve a multi-faceted chronic disease problem you need the support of the system to be multi-modal as well. Currently, the system is not equipped to provide this multi-disciplinary support.”
“We must accept that these latest changes will bring some immediate transitional pain and discomfort, but what we need first and foremost is for doctors and pharmacists to work together,” Ms McSwan told the AJP.
“The fact that many people have been on opioids for a long time means they will need a good deal of help and a review, but they also need to be respectfully educated on where opioids sit and where they don’t.
“These patients will need lots of reassurance. For many people it’s going to take time to accept these changes. We mustn’t stop trying. After all, changing a person’s behaviour takes time, it doesn’t happen overnight.
“It’s important to be patient, if we are not, it will cause forced withdrawals, great disability and will compel people to consider illegitimate use. At the coalface I would encourage pharmacists to get in touch with their surrounding doctors, as this is a joint issue. The doctors are struggling too.
“It may take time but this is something we need to do; we have no other solution. The doctor and pharmacist together have the skills to be able to manage this and do the best by their patients.
“It’s a great opportunity for comradeship and synergy of skill. Step one is to start with your own local community; look at who you can work with and take one case at a time.
“See this as a fabulous opportunity to support the patient while building new relationships.
“Of course, there are going to be transitional discomforts but that is where the opportunity lies. No pain, no growth—so look at how you can rethink the way you currently do things, how can you operate differently while supporting the patient.
“We’re talking about change behavior and no one is going to change how they act when they’re feeling anxious.
“When the patient sees everyone working together they feel supported and will be more willing and trusting to change. This then allows you to slowly reduce doses or introduce alternatives,” advises Ms McSwan.