The Pharmacy Council continues to receive complaints that involve a lack of oversight by proprietor pharmacists. The Pharmacy Board of Australia (PBA) Guidelines for proprietor pharmacists provides clear guidance for proprietors in relation to their roles and responsibilities, and how he or she must vigilantly maintain an active interest in how the practice of pharmacy is being conducted. This applies regardless of whether their ownership is 1% or 100% of the pharmacy business.
The Proprietor Guidelines state that a registered pharmacist who owns a pecuniary interest in a pharmacy must:
- maintain, and be able to demonstrate an awareness of, the manner in which the pharmacy business is being conducted; and
- where necessary, intervene to ensure that the practice of pharmacy is conducted in accordance with the applicable laws, standards and guidelines.
Non-compliance with the Guidelines is a breach of a pharmacist’s professional obligations.
A proprietor/owner or partner-in-ownership of a pharmacy cannot delegate his or her professional obligations, even if that partner is not regularly present at the pharmacy. This applies to pharmacists who own a pharmacy, or pharmacies, in all forms of business structures.
Therefore a pharmacist proprietor cannot be a ‘silent’ partner and is expected to take an active role. In addition, a pharmacist proprietor residing interstate, cannot claim to be ignorant of the laws and regulations of the state or territory in which the pharmacy premises are located. The proprietor’s responsibilities include ensuring compliance with any state or territory legislation regarding facilities and equipment, and maintaining an awareness and responsibility for goods sold and the services being provided at the pharmacy
Two recent cases that were reported to the Pharmacy Council and Health Care Complaints Commission (HCCC) involve proprietors who were unaware of issues that were occurring in their pharmacies that created risk to the health and safety of the public because they did not have oversight of their pharmacies.
A report to the Council identified the loss and possible diversion of large amounts of schedule 8 drugs from Pharmacy A: over 6000 oxycodone 5 mg tablets, over 1000 oxycodone 10mg, and over 1000 alprazolam tablets of various strengths were unaccounted for.
The pharmacist proprietor of Pharmacy A stated that he relied on the franchise group to provide oversight of the pharmacy. He indicated that he visited his pharmacy every 2-3 months as a ‘mystery shopper’, and the employees of the pharmacy were unaware he was the proprietor. Due to the unexplained loss of the large quantity of schedule 8 medicines, and the potential risk of these medicines to the community, the Pharmacy Council imposed conditions on the pharmacist’s registration. He was required to review the procedures in the pharmacy, and to undertake regular audits in all aspects of the pharmacy business. After several months the proprietor demonstrated his improved oversight in the services provided in his pharmacy. He presented his reflections on the roles and responsibilities of his improved oversight and knowledge of his business to the Council, and subsequently all conditions were removed from his registration.
Following an investigation by the Pharmaceutical Services Unit into the prescribing practices of Dr X, a General Practitioner, Dr X was prohibited from possessing, supplying or prescribing any drug of addiction and any prescribed restricted substance (schedule 4 appendix D drug). Pharmacy B was identified as having dispensed a number of prescriptions written by Dr X. The pharmacy proprietor had a financial interest in a number of pharmacies in 3 different States and rarely visited the pharmacy. A subsequent investigation by the Pharmaceutical Regulatory Unit (PRU) identified numerous breaches of the Poisons and Therapeutic Goods legislation at Pharmacy B, which included but was not limited to:
- Dispensed large quantities of potent Schedule 8 drugs where the quantity and/or purpose does not accord with the recognised standard.
- Dispensed large quantities of schedule 8 drugs to at least 5 patients where the oMEDD [oral morphine equivalent daily dose] ranged from 180-806mg.
- Dispensed schedule 4D medicines at short intervals and/or in excessive quantities.
- Dispensed numerous invalid prescriptions.
- Failed to undertake mandatory stock checks.
- Poor record keeping of schedule 8 drugs.
These breaches had the potential to cause significant harm to individuals and negatively impact the community. The proprietor had failed to exercise adequate oversight of the operations of Pharmacy B and failed to comply with the PBA guidelines for proprietor pharmacists.
The pharmacy proprietor’s registration was initially suspended by the Council. However, following improvements identified and made by the pharmacist and his co-proprietors, the suspension was lifted and conditions were imposed requiring the pharmacist to undertake regular visits to the pharmacy to audit all aspects of the business. Following evidence of compliance with the legislation and the guidelines all conditions were removed.
To ensure compliance with the Board Guidelines, proprietor pharmacists need to demonstrate oversight of their business. This is shown by activities such as interacting with co-proprietors and staff; ensuring policies and procedures are in place for all services and staff are suitably trained; conducting regular on-site visits; and undertaking regular audits and inspections of all aspects of the pharmacy business. Proprietors must comply with all legislation relevant to the practice of pharmacy and must ensure the pharmacy is providing a service that ensures safe health care delivery for the public.