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Navigating the rules: Setting up a PBS pharmacy in a large medical centre

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In this article, we outline some of the requirements necessary for the ACPA to grant approval for a new PBS pharmacy in a large medical centre

Understanding large medical centres

To qualify as a ‘large medical centre’, the proposed premises must fit within the criteria defined in the Rules. A key requirement is that the medical centre (of which the new pharmacy will be part) operates under single management.

What you need to know

A large medical centre may comprise the general medical practice and the pharmacy, and may accommodate subleases or licences with dental practitioners, pathology, and allied health providers who occupy part of the centre.

One of the most challenging aspects of an application under Item 136 is negotiating arrangements which (a) are commercially satisfactory to each of the occupants of the medical centre, and (b) fit within the requirements of the Rules.

Item 136 of the Pharmacy Location Rules (Rules) sets out the requirements which must be met before the Australian Community Pharmacy Authority (ACPA) can approve a new PBS pharmacy in a large medical centre.

Management responsibility challenges

It’s common for the general medical practice to be hesitant about assuming responsibility for the maintenance of the entire centre, especially where individual occupants have their own maintenance responsibilities under their own lease or licence. In these circumstances, it can assist in establishing a legal agreement between the occupants of the medical centre delineating responsibilities for marketing, maintenance, and administration of the centre as a whole.

Meeting PBS subscriber requirements

Another crucial requirement to be satisfied is the Authority is satisfied that, during the two months before the day on which the application is made and until the day the application is considered by the Authority, the number of PBS prescribers at the medical centre is equivalent to at least eight full-time PBS prescribers, of which at least seven PBS prescribers must be prescribing medical practitioners.

PBS prescribers include medical practitioners, participating dental practitioners, authorised optometrists, authorised midwives, and authorised nurse practitioners. To achieve the minimum number of hours required to meet the equivalent of 8 full-time PBS prescribers, the medical centre must account for a total of 304 hours per week (the equivalent of 38 hours weekly). In addition, the medical centre must be open for general practice appointments for a minimum of 70 hours per week and ensure one or more prescribing medical practitioners is available during at least 70 of those operational hours.

Accurate record keeping is key

Great attention to detail will be required on the part of the medical centre to record the real-time working hours (start and finish times) of the PBS prescribers included in support of the application. This documentation should also reflect any breaks or periods when prescribing is not taking place. All PBS prescribers must confirm their prescriber and provider numbers and declare there are no conditions attached to their registrations preventing them from prescribing under the PBS.

Gathering this evidence and providing it to the ACPA in an understandable format is key to a successful application under Item 136 of the Rules, as is high levels of co-operation and support between the pharmacist applicant, the owner of the medical practice, and the PBS prescribers who occupy the medical centre.

Preparing for potential deferrals

Applicants and those who are providing evidence for an application should be prepared for the possibility of the ACPA deferring the application, particularly if there are objections raised from nearby pharmacists. In those circumstances, the applicant, the medical practice, and the PBS prescribers should be prepared to continue to gather and record the necessary evidence regarding hours of operation of the medical centre and the working times and days of the PBS prescribers, at least until the deferred ACPA meeting.

Single management is defined as:

  1. an arrangement in which a single entity, or two or more entities working cooperatively under an agreement, are responsible for marketing, maintenance and administration for the centre as a whole, and
  2. does not include independent owners or tenants of premises of a building or centre that cooperate:
    • on occasions; or
    • in relation to some but not all the matters mentioned in subparagraph (a) in relation to the building or centre