About the survey
The community pharmacy compliance survey (CPCS) is designed to help community pharmacies comply with the new Medicines and Poisons Act 2019 (MPA) and its supporting regulations and standards.
The MPA and the Medicines and Poisons (Medicines) Regulation 2021 (MPMR) have repealed and replaced the Health Act 1937 and its regulations. The new medicines and poisons legislative framework came into effect on 27 September 2021.
To help community pharmacies prepare to comply with the MPA and MPMR, it was proposed inspectors from the Pharmacy inquiry response program (PIRP) conduct a site visit to every community pharmacy in Queensland over a 2 year period up to December 2021.
Online survey replacing site visits
On 8 April 2020, the CPCS site visits were suspended due to COVID-19 restrictions and the impact of COVID-19 on the community pharmacy industry. Site visits were replaced with an online survey, which commenced in March 2021. The survey is being rolled out in stages across Queensland.
PIRP inspectors will make phone contact with each community pharmacy to explain the purpose of the online compliance survey and the change of process. Each community pharmacy is provided a unique ID number and a link to the online survey. The survey should be completed within 4 weeks of receiving the link.
Pharmacists can prepare for the survey and assess their level of compliance with the new legislation by reviewing the survey questions for Parts A and B (PDF 184 kB), which is to be complete by all pharmacies, and Part C (PDF 150 kB), which is to be completed by pharmacies that prepare and dispense compounded products. Please note these documents are for reference only, they cannot be submitted.
Pharmacy inquiry response program inspectors
Inspectors from the PIRP team have been appointed pursuant to Section 131 of the Medicines and Poisons Act 2019, they will oversee the completion of 1 CPCS for each community pharmacy within Queensland.
They will review the results of the CPCS and will discuss the outcome with the parmacy, providing support to remedy any issues that may be identified. Inspectors may also notify other authorities, such as a public health unit of a compliance outcome. Read Read information on how privacy and confidentiality will be maintained throughout the CPCS.
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 assistants' 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 medicines leglsation 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 pharmacy ownership compliance reviews being undertaken for the Pharmacy Business Ownership Act 2001.
Transition to the Medicines and Poisons Act 2019
An important element of the CPCS process is to raise awareness of, and facilitate the transistion to the MPA, the MPMR and the associated departmental standards. The CPCS has been purposefully designed as an educative process to assist community pharmacies to establish processes to support minimum compliance.
Under the MPA, 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. Compliance offences for not having an SMP do not commence until 27 September 2022.
Pharmacists will have an opportunity to discuss the regulatory changes with one of our inspectors during the CPCS process. What pharmacists need to know - the new Medicines and Poisons Act 2019 (PDF 555 kB) is an education document designed to assist pharmacists in understanding the new legislative framework, and the real-time reporting of monitored medicines, a new system known as QScript.
Outcome of the survey
After all participating pharmacies have completed a CPCS, the results will be analysed and the overall outcome of the compliance survey will be publicly available. Only de-identifiable, aggregated information will be released; measures will be taken to ensure confidentiality and privacy is maintained.
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
- Medicines and Poisons (Medicines) Regulation 2021
- Medicines and Poisons Act 2019
- Real-time reporting of monitored medicines
If you require further information in relation to the CPCS, contact the Pharmacy inquiry response program compliance team:
Phone: 0448 608 556