Community pharmacy compliance survey
The Community pharmacy compliance survey has been designed to help community pharmacies prepare to comply with the upcoming introduction of the new Medicines and Poisons Act 2019 and supporting regulations and standards. The new Act will repeal and replace the current Health Act 1937 and its regulations. It is expected the new Act will take affect mid-2020.
One proactive compliance site visit of all community pharmacies throughout Queensland will be completed by inspectors from the Pharmacy inquiry response program (PIRP) over the next 2 years up to December 2021.
Pharmacists can prepare for the compliance site visit by completing the self-assessment checklist to assess their readiness to comply with the new regulations and standards.
Background
On 16 April 2019, the Government tabled its response to the Health, Communities, Disability Services and Domestic and Family Violence Prevention Committee’s report on its inquiry into the establishment of a pharmacy council and transfer of pharmacy ownership in Queensland.
The Committee’s report made 11 recommendations relating to:
- pharmacist and pharmacy assistance scope of practice
- the establishment of pharmacy advisory council
- the regulation of pharmacy ownership in Queensland
- communication of pharmacy services.
The government accepted all of these recommendations in full or in principle.
To deliver on recommendation 10 and 11 of the report, a temporary inspectorate was established to:
- Improve transparency regarding the compliance of pharmacists pursuant to the Pharmacy Business Ownership Act 2001, the Health Regulation 1996 (HR) and the Health (Drugs and Poisons) Regulation 1996 (HDPR) by publishing its compliance audit results, at least annually.
- Improve communication to consumers regarding the provision of the services community pharmacies offer in a public facing platform.
It is important to note that the community pharmacy compliance survey is different from the compliance reviews being undertaken for the Pharmacy Business Ownership Act 2001.
Medicines and Poisons Act 2019
We will also be supporting the transition to the Medicines and Poisons Act 2019 which came into law on 26 September 2019; although it will commence at a later date. On its commencement, the Medicines and Poisons Act 2019 and supporting Regulations will repeal and replace the Health Act 1937 and current regulation.
Under the new Medicines and Poisons Act 2019, a community pharmacy will require a substance management plan (SMP). A SMP is a document which is based on identifying and managing known and foreseeable risks associated with regulated activities and substances. A community pharmacy may already have existing policies, procedures and accreditation documents, which will contribute to the development of the SMP.
Pharmacists will have an opportunity to discuss the regulatory changes with one of our inspectors during the compliance site visit.
Further information
The inquiry, new legislation and regulatory framework
- Parliamentary Committee’s Inquiry into the establishment of a pharmacy council and transfer of pharmacy ownership in Queensland
- Queensland Government Response to the Health, Communities, Disability Services and Domestic and Family Violence Prevention Committee’s Report No. 12 – Inquiry into the establishment of a pharmacy council and transfer of pharmacy ownership in Queensland
- New medicines, poisons and pest management regulatory framework
Compliance and site visits
Contact the Pharmacy inquiry response program comliance team on PIRP.Survey@health.qld.gov.au or (07) 3708 5258.
Frequently asked questions
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Why was the Pharmacy inquiry response program established?
The Pharmacy inquiry response program (PIRP) was established in response to Report No. 12, 56th Parliament – Inquiry into the establishment of a pharmacy council and transfer of pharmacy ownership in Queensland (the Inquiry). The recommendations relevant to the compliance survey include:
- Recommendation 10: Improve transparency regarding the compliance of pharmacists pursuant to the PBO Act 2001, the Health Regulation 1996 and the Health (Drugs and Poisons) Regulation 1996 by publishing its compliance audit results, at least annually.
- Recommendation 11: Improve communication to consumers regarding the provision of services community pharmacies offer in a public facing platform.
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Who are the inspectors with the Pharmacy inquiry response program?
Inspectors from the Pharmacy inquiry response program (PIRP) have been appointed pursuant to section 137 of the Health Act 1937 and will be completing one proactive compliance site visit of your community pharmacy within Queensland by December 2021.
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What is the purpose of the community pharmacy compliance survey?
The compliance survey has been established to guide and facilitate the transition to the proposed incoming medicines regulation and provide a consistent baseline compliance level within the community pharmacy environment.
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Will I be notified when the inspector with the PIRP Team will be attending my pharmacy?
Yes, the pharmacist will receive notification of attendance detailing the specific date and time of the physical site visit approximately one month prior to the physical site visit.
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Can I change the allocated appointment for my compliance survey?
Please contact the PIRP team as soon as possible to discuss possible alternatives:
Email: PIRP.Survey@health.qld.gov.au
Phone: (07) 3708 5258 -
How can I prepare for the compliance survey?
In preparation for the compliance survey, the pharmacist will receive notification of attendance and a self-assessment form prior to the compliance site visit.
The pharmacist is not obliged to complete and return the self-assessment; however, the form has been designed to provide guidance and direction for the upcoming compliance survey. The self-assessment will not replace the compliance site visit.
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Do I have to complete the self-assessment?
No, there is no requirement for you to complete the self-assessment.
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What legislation will the community pharmacy compliance survey be assessed against?
The questions on the self-assessment checklist and compliance survey relates to the Health (Drugs and Poisons) Regulation 1996, Health Regulation 1996 and incoming medicine and poisons regulation. We are only reviewing your compliance against identified high risk areas in pharmacy practice, sections of the legislation we believe needs further clarification or areas that are anticipated to change under the new legislation. We will not be conducting an exhaustive review of your compliance against the legislation.
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What happens if issues are identified during the compliance survey?
After the compliance survey, the inspector will discuss the outcome and provide support to remedy any issues identified. We may also notify other authorities of the compliance outcome.
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How long will the PIRP compliance site visit take?
It is anticipated the compliance survey will take approximately 60-90 minutes to complete. A registered pharmacist may be required to provide information to the Inspectors. However, we are mindful your pharmacy is an operational business; therefore, disruption to your service provision will be kept to a minimum.
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How often will a compliance survey be undertaken by Inspectors with the PIRP team?
Only 1 compliance site visit will be completed in your pharmacy by an inspector.
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Will the outcomes of the compliance survey be published/reported?
The overall outcomes of the compliance survey will be publicly reported annually. We will ensure that confidentiality is maintained.
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Will public health units continue to conduct regulatory activities?
The compliance surveys completed by inspectors with the PIRP team will not replace the regulatory activities conducted by your local public health unit.
Public health units will continue to operate business as usual.
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How will you ensure that privacy and confidentially is maintained?
The PIRP team takes your privacy seriously. Personal information collected and stored is protected by the Information Privacy Act 2009 (Qld), Part 7 of the Hospital and Health Boards Act 2011 (Qld), Code of Conduct for the Queensland Public Service and Queensland Health's Privacy Plan.
Information will be retained in line with the Public Records Act 2002 (Qld).
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How can I provide feedback?
Your feedback, either positive or negative, is important to us. Please provide feedback to PIRP.Survey@health.qld.gov.au.
