INSIGHTS: The changing state of play: The natural evolution of the professional regulation of pharmacy

February 29, 2016

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The revised suite of Guidelines issued by the Pharmacy Board of Australia (National Board) came into force on 7 December 2015. It is important that employee and locum pharmacists are aware of the revised Guidelines for Proprietor Pharmacists. The reason for this is twofold:

  • first, it is important to have a working knowledge of how the National Board regulates proprietor pharmacists and the importance placed on a pharmacy’s systems, procedures and protocols
  • second, it provides a good guide to assess any prospective employer/workplace against.

The focus of this article is the revised Guidelines for Proprietor Pharmacists (the revised Guidelines). The revised Guidelines have replaced the Guidelines on Responsibilities of Pharmacists when Practising as Proprietors (the previous Guidelines).

The National Board has split the previous Guidelines into three separate guidelines and use stronger language and provide more detail. It appears that the intention of the revised Guidelines is to ensure there is no doubt regarding the level of active involvement the National Board expects a proprietor pharmacist to take in the conduct of their pharmacy(s).

The revised guidelines

Guideline 1: Proprietors are to maintain an active interest in how the pharmacy business is being conducted

Guideline 1 still requires the proprietor pharmacist to ensure the pharmacy operation is being conducted in accordance with:

  • any applicable State, Territory and Commonwealth laws
  • National Board policies, codes and guidelines and
  • Good pharmacy practice

It also still requires a proprietor pharmacist “who finds that the practice of pharmacy does not operate in accordance with these legal/professional obligations, to intervene and ensure that the pharmacy business is conducted properly”.

However, Guideline 1 uses different language of the previous Guidelines. Instead of requiring proprietor pharmacists to “determine regularly how the practice of pharmacy is conducted” they must now “vigilantly maintain an active interest in how the practice of pharmacy is being conducted”. This is a notable shift in language that places a stronger emphasis on proprietors being actively involved in the day-to-day running of their pharmacy(s).

Guideline 2: Proprietor pharmacists cannot delegate their professional obligations

Guideline 2 replicates a clause that existed in the previous Guidelines. It makes it clear that the proprietor pharmacist cannot delegate their professional responsibilities under the revised Guidelines, even if they are not regularly present at the pharmacy business. It applies to all pharmacists who own a pharmacy, or pharmacies, in all forms of business structures.

Guideline 3: Responsibilities of proprietor pharmacists

Much like the previous Guidelines, Guideline 3 prescribes specific actions a proprietor is expected to take. It is not an exhaustive list, so should not be interpreted as excluding from a proprietor’s responsibilities those actions that are not included. However, it should be interpreted as prescriptive insofar as it explicitly lists responsibilities.

Taking the above on board, the list set out in the previous Guidelines has been extended to include, for example:

  • proprietors assuring themselves that the pharmacists they employ are complying with and adhering to the Board’s registration standards and guidelines, and where applicable, make any necessary arrangements that facilitate pharmacists meeting these requirements
  • ensuring compliance with any State or Territory legislation regarding facilities and equipment required for the types of services delivered at the pharmacy
  • ensuring risk management procedures are in place for the operation of the pharmacy, including all types of services delivered at that pharmacy
  • ensuring patient information is appropriately stored and accessed
  • ensuring the pharmacy is suitably resourced, and that staff members are suitably trained and appropriately supervised to provide services in accordance with their position descriptions
  • maintaining an awareness of and responsibility for the services being provided including unregulated services, and goods being sold, particularly those known to be subject to abuse or misuse and those not regulated through the Therapeutic Goods Administration or the pharmacy premises registering authorities
  • ensuring business procedures, policies and protocols are developed, implemented and routinely followed for all services delivered at the pharmacy
  • ensuring that advertising of services and/or products sold at the pharmacy is carried out in accordance with applicable legislation and guidelines

A further important difference between Guideline 3 and the previous Guidelines is (apart from the extended list of responsibilities) is change in language. The responsibility of the proprietor is described as one to “ensure the pharmacy business is conducted properly”; rather than to “determine regularly how the practice of pharmacy is conducted. Again, it is a notable shift in language that places a stronger emphasis on proprietors being actively involved in the day-to-day running of their pharmacy(s).

Going forward

The drafting of the revised Guidelines is a clear indication that the National Board views proprietor pharmacists as holding the primary responsibility within a pharmacy. Going forward, we anticipate that the National Board will have little tolerance for proprietor pharmacists that decide to take a “back seat” in the administration and management of their pharmacy(s). We recommend that all proprietor pharmacists take the New Year to review their current management and administration arrangements to ensure that there are working within the requirements of the revised Guidelines.

Contact Kellie Dell’Oro, Principal if you have any questions.