SHPA calls for tightened S8 opioid restrictions

Article courtesy of the Australian Journal of Pharmacy

The SHPA has suggested limiting pack sizes, indications and dose limits for S8 opioids.

In its submission to the TGA’s consultation on S8 opioid use and misuse in Australia – options for a regulatory response, the SHPA also suggests limiting the duration of a script’s validity.

“SHPA is pleased to see that recent regulatory action on the scheduling of codeine-containing medicines has evolved into a broader discussion on opioids,” it says in the submission.

“Research from the Pennington Institute has found that the use of opioids in Australia has quadrupled from 22 million doses prescribed to patients in 2001, to 106 million doses in 2016.

“As hospital pharmacists, SHPA members often see the worst of opioid misuse and abuse in inpatient wards and in emergency departments.”

In the consultation, the TGA set out a number of suggested options for combating issues around S8 opioids, in a bid to prevent Australia from developing an “opioid crisis” similar to that being experienced by the United States.

The SHPA says it would like to see the first three of these prioritised, as “they would have the largest impact on medical and pharmacy practice to reduce inappropriate opioid use in the community”.

The first suggestion was to “consider the pack sizes for strong (S8) opioids,” and SHPA says it supports the provision of smaller packs, as already commonly occurs at discharge from hospital.

“Research conducted by the Centre for Disease Control in USA has demonstrated that the quantity of opioids supplied on initial prescription positively correlates with probability of prolonged use of opioids,” SHPA writes. “Patients receiving initial opioid prescription of one-day supply only had a 6% chance of being on opioids for a year or longer, compared with 10% chance for patients supplied with five-days supply.

“Patients receiving 14-days supply, which is the standard pack-size for sustained release opioids in Australia, had a 25% chance of remaining on opioids one year later.”

SHPA also says it strongly agrees with the TGA’s second suggested option: that a review of the indications for S8 opioids be considered.

“The outcomes of these reviews should also result in Product Information and Consumer Medicine Information resources being updated to reflect evidence-based practice,” it says.

“The findings should also inform PBS restrictions placed on these medicines such that they are not prescribed and dispensed inappropriately.

“For example, sustained released opioids are not recommended for use in the treatment of acute pain according to current practice guidelines, but members observe these medicines are regularly prescribed to treat acute pain.”

The SHPA also says there are potential merits to further restricting high-dose opioid medicines, such as specialist/authority prescribing, and this warrants further consultation.

“SHPA believes that a review of indications and clinical evidence for high dose opioids is justified, however further restrictions to prescribing must be evidence-based and should also not become a significant regulatory burden on prescribers and pharmacists.”

Pharmacists must be adequately recognised and supported to monitor access and supply of opioids should their prescription be circumscribed, it says.

The SHPA also called for a review of prescription validity time frames.

“A concern not addressed in the consultation is opioid prescriptions being valid for up to twelve months, whereas some states have six months validity.

“It is inappropriate that pain medicines meant to be used to address acute pain can have a validity for up to twelve months, well after the acute pain is expected to subside. SHPA believes the prescription validity timeframes should be reviewed to align them with pain management plans and treatment goals.

“Prescribers should also be empowered to endorse prescriptions with a shorter expiry date where relevant.”

SHPA President Michael Dooley told the AJP that “SHPA supports appropriate and effective regulatory action by the TGA to curb the misuse of opioids“.

“SHPA members often see the worst of opioid misuse and abuse on inpatient wards and in emergency departments, “ he says.

“However it’s not enough just to regulate, cohesive government policy in this important area would also influence prescribing drivers, such as PBS quantities, to support dispensing of smaller quantities”

“Hospital pharmacists are judicious clinicians and key members of the multidisciplinary team in hospitals, often advising doctors of appropriate pain medicine prescriptions and establishing pain management plans and opioid de-escalation plans. Hospital pharmacists are also represented on Acute Pain Service teams and are the leading clinicians in emerging opioid stewardship services.

“As the first pharmacy organisation to unequivocally support last month’s upscheduling of codeine, SHPA has long been interested in evidence-based policy development for opioids and other analgesics.

“With the increasing acknowledgement of opioid misuse we recognise the key role that hospital pharmacists can play and are looking forward to further engaging our members and continuing to collaborate with medical colleges and patient groups as part of this growing effort.’’

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