Changes to S8 pack sizes on the cards?

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PSA and SHPA are at odds with the Guild in their support of changes to pack sizes, while some pharmacists have voiced concerns about stock management, logistics and cost

The TGA has released submissions to its consultation into options for a regulatory response regarding prescription strong (Schedule 8) opioid use and misuse in Australia.

In its consultation paper, the first option was to consider the pack sizes for S8 opioids, requiring sponsors to register and make available for supply both smaller (such as maximum three-day) pack sizes for treatment of patients with acute pain and suitable pack sizes (14 or 28-day) for treatment of people with chronic pain due to malignancy.

PSA has responded saying that availability of smaller pack sizes of S8 opioids may be suitable for cases where relief of acute pain necessitates short-term therapy with opioids.

“Pharmacists observe firsthand that prescribers tend to order a designated quantity such as the maximum quantity listed on the PBS or whatever pack size is readily available,” says the PSA in its submission.

“Whilst best practice would dictate that the total quantity prescribed should reflect therapeutic need and dosing regimen, prescribers rarely order quantities less than the maximum Government-subsidised quantity or commercially available pack size quantity.”

A significant proportion of patients being dispensed large pack sizes of opioid medicines on hospital discharge are “at risk of starting on their path towards addiction”, says the PSA.

SHPA agrees with the PSA position, saying it supports provision of smaller packs and would like to see this option prioritised.

“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 says.

“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.”

The Pharmacy Council of New South Wales says it supports the proposal to require sponsors to make available for supply:

  • smaller (e.g. three days maximum) pack sizes for treatment of patients with acute pain, where these changes do not put an unfair cost burden on patients; and
  • suitable (e.g. 14 or 28 days) pack sizes for treatment of patients with chronic pain from malignancy, provided that access to treatment for these patients is not reduced.

“Further consideration should be given to providing fair remuneration to pharmacists should the prescribed treatment require original packs to be broken for dispensing the prescribed quantity,” it says.

The Public Health Association of Australia (PHAA) also said that it “strongly supports” the option requiring sponsors to make available smaller pack sizes, “as being a sensible prevention measure”.

“With risks of long-term use increasing after as little as give days taking prescription opioids, patients should not be prescribed more than they are likely to require,” says the PHAA.

“However, there should be a clear effort to ensure reasonable access for people who are in palliative care,” it adds.

Pharmacy Guild: Max quantity more important

Meanwhile the Pharmacy Guild of Australia disagrees that changing pack sizes will impact on prescribing patterns.        

“The Guild believes that changing the marketed pack size does not have an appreciable effect on prescribing habits as the prescriber can order any quantity irrespective of the size of the pack marketed by the sponsor,” the organisation says in its submission.

“There is no compulsion to write a prescription consistent with the pack sizes supplied by a sponsor and community pharmacy is accustomed to breaking original packages or dispensing multiple packs to accommodate the quantity ordered by the prescriber.

“The Guild believes that, in practice, requiring the sponsor to register and make available smaller pack sizes will have little impact on practice as this is not a strong determinant of prescribing,” it says, adding that the quantity of a medicine prescribed can be influenced by a number of factors, including PBS listing status of a medicine; manufacturer pack size; intended length of treatment; and dose.

Prescribing software default quantity has an effect on prescribing habits but this depends on the PBS status of the medicine and the amount of PBS subsidy that the medicine attracts, the Guild says.

“The less expensive a medicine is, the less effect any PBS restriction has because there is no price signal to the prescriber and/or consumer.

“The Guild believes that changing pack size has less effect than changing the PBS Max Quantity.

“However changing the Maximum Quantity of a PBS-listed item that attracts a negligible PBS subsidy has very little effect on the quantity prescribed because prescribers/patients can elect to access medicines as private prescriptions.”

Concerns: Cost, storage

PSA cites pharmacist concerns surrounding stock management and logistics when it comes to introducing smaller pack sizes for S8s.

“Firstly, when small pack sizes are introduced the range of products (and what stock a pharmacy needs to keep) will increase,” it says, adding that there are issues regarding physical space requirements as well as cost to comply with storage requirements.

“Concern has also been expressed regarding the trend observed by pharmacists that the introduction of smaller pack sizes invariably results in an increase in unit price of the medicine.”

In its submission to the TGA, the Pharmaceutical Benefits Advisory Committee (PBAC) adds that while the premise of smaller pack sizes “seems logical and may reduce waste”, there are issues regarding cost and availability.

“If smaller pack sizes are available internationally, the cost impost of adding pack sizes … from an industry perspective will be higher if the packs are not otherwise available for other markets,” says the PBAC.

“In this instance, sponsors may request that the additional costs be passed on and therefore there will be cost, pricing and expenditure considerations.

“Time to availability of new pack sizes would include time for manufacturing considerations such as a scale-up if required, manufacturing changes such as labels in addition to registration of new packs.

“If there will be new and different packs, there will [also] be labelling considerations.”

AMA says it supports the availability of smaller pack sizes, “as long as larger pack sizes are still available”.

“Smaller pack sizes would also be useful in preventing waste in the treatment of end-stage palliative care patients,” it says in its submission.

“AMA members report that a patient may sometimes only require one or two doses at end of life, but only the larger pack size is available for prescription.”

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