Limits on dispensing and sales of prescription and over-the-counter medicines

On 23 December 2022, we released an updated statement on limited dispensing and supply of medicines.

On 1 July 2020, we published a statement indicating that childrens' liquid paracetamol products can return to the front of counter. However, dispensing limits still apply.

In order to ensure equitable access to medicines for all Australians, the Pharmacy Guild of Australia and the Pharmaceutical Society of Australia, in consultation with the Department of Health, are requiring community pharmacists to enforce new limits on dispensing and sales of prescription and over-the-counter medicines. This measure is also supported by the National Pharmaceutical Services Association, representing pharmaceutical wholesalers.

Demand for medicines increased markedly during the first two weeks of March in response to the COVID-19 pandemic. This resulted in pharmacies and wholesalers reporting numerous product lines out of stock. These temporary, local-level out-of-stocks have resulted in challenges for Australian consumers.

Medicines sponsors (pharmaceutical companies) report that they do not anticipate imminent or widespread national level medicine shortages resulting from the impact of COVID-19 on medicines manufacturing or logistics. However, if current levels of demand through excessive purchasing continue, supply interruptions will occur at both the national level while sponsors await scheduled deliveries of new stock from international manufacturing sites and at the local level as a result of stockpiling by pharmacy customers.

It is critical to protect the access of medicines for Australians. There will be certain requirements for community pharmacists, as follows:

• pharmacists will be required to limit dispensing of certain prescription products to 1 months' supply at the prescribed dose, and sales of certain over-the-counter medicines to a maximum of one unit per purchase.

  These limits apply to particular classes of medicines for which unavailability or an interruption to treatment could result in significant health impacts, or which are expected to be subject to increased consumer demand associated with the COVID-19 pandemic. The list includes over-the-counter medicines such as glyceryl trinitrate, adrenaline autoinjectors and salbutamol inhalers (Ventolin) and prescription products such as asthma and COPD medicines, insulins and oral hypoglycaemics and anti-epileptics. The complete list is provided at Attachment A. Other medicines may be added to the list in the coming weeks.

• in addition, pharmacists will be strongly encouraged to limit dispensing and sales of all other medicines to one months' supply or one unit.

  Dispensing of multiple repeats is permitted only for valid Regulation 49 prescriptions, which must only be written by prescribers. PBS Regulation 49 must be used sparingly and only in exceptional circumstances in accordance with the legislated criteria. If pharmacists have doubts about the appropriateness of particular Regulation 49 prescriptions please discuss this with the prescriber.

  Two over-the-counter medicines for which there has been particularly high demand will be subject to new controls on the supply of these medicines:

  • Salbutamol inhalers provided on an over-the-counter basis will be subject to new controls. Pharmacists will be required to confirm that supply is appropriate by confirmation of the patient's symptoms, label the product indicating to whom it has been dispensed and record the supply
  • Pharmacists will be required to place paracetamol paediatric formulations behind the counter to assist in allocating supply equitably.

In addition, only one salbutamol or paracetamol paediatric product should be supplied per customer.

The Pharmacy Guild, the PSA and the National Pharmaceutical Services Association have agreed that these limits on pharmacy sales will be accompanied by limits on orders from wholesalers, to ensure equitable distribution of stock, including to regional and rural pharmacies.

Supply of quantities that are not clinically required for an individual may be illegal under State and Territory law and contravene Pharmacy Board Professional Practice guidelines.

Medicines where interrupted supply could result in serious health consequences - prescription

Pharmacists are required to limit dispensing of the below prescription medicines to one months' supply at the prescribed dose.

Medicines that may be subject to increased demand due to COVID-19 symptom management - prescription

Pharmacists are required to limit dispensing of the below prescription medicines to one months' supply at the prescribed dose.

Medicines where interrupted supply could result in serious health consequences - non-prescription

Pharmacists are required to limit sales of the below non-prescription medicines to one unit per purchase.

Medicines that may be subject to increased demand due to COVID-19 symptom management - non-prescription

Pharmacists are required to limit sales of the below non-prescription medicines to one unit per purchase.