Regulators to focus on pharmacy ownership and franchise arrangements
The Victorian Pharmacy Authority is set to introduce an audit program this year that will focus on pharmacy business commercial arrangements, in particular undeclared and unlawful interests in pharmacy businesses.
In its latest communique, the VPA says it will work to broaden its work, continuing to consult with its interstate counterparts to “explore their experience and share information on detecting and dealing with undeclared ownership”.
“Extensive work has been undertaken towards development of the audit program and this work is continuing,” said VPA chair Toni Riley in the communique.
“It is likely that the audit program will include ownership audit and financial audit components”.
The VPA says the audit program will be risk-based, but partially randomised.
Business arrangements falling into the high-risk category include:
• those involving complex and technical commercial arrangements;
• those for which there is any indication there may be undisclosed proprietary interests or
undue influence; or
• apparent gaps in the documentation supplied by the applicant.
“Guidelines on pharmacy business commercial arrangements are currently being developed to assist applicants and stakeholders to understand the requirements of the Act [Pharmacy Regulation Act 2010] and facilitate the possible future introduction of certification requirements,” the VPA says.
Publication of these guidelines is expected to commence in February 2018.
Meanwhile, the VPA says it has also implemented a risk-based program of targeted inspections to evaluate facilities where pharmacists undertake sterile compounding, including those in hospitals and pharmacies.
“The program aims to ensure provision of safe and suitably controlled working environments with respect to product and patient safety. In cases where inspections identify non-compliance or concerns, licensees may be required to undertake risk assessments to identify potential risks and suitable mitigations,” the VPA bulletin stated.