Published: 5 September 2019

Publications

Pharmacy quality audits

Prescriber Update 40(3): 54-56
September 2019

Key Messages

  • Pharmacy premises in New Zealand are audited by Medsafe to ensure pharmacy services to the public meet the required standards.
  • In early 2018 Medsafe rolled out inspection audits nationwide as the next step in the implementation of the risk-based Pharmacy Quality Audit Framework.
  • Medsafe was pleased by the continued trend of improvement in performance for the January to March 2019 quarter. Medsafe looks forward to seeing an increase in the rate of improvement.


The Medicines Control team within Medsafe is responsible for regulating the medicine supply chain in New Zealand. As part of this function, Medsafe audits pharmacy premises to ensure that the pharmacy services to the public meet the required standards.

This article provides a brief overview of the:

  • types of Pharmacy Quality Audits
  • findings from January to March 2019
  • some preliminary findings from follow-up audits conducted between April and early June 2019.

Pharmacy Quality Audit Framework

The roll out of unannounced inspection audits nationwide in early 2018 marked a significant step in the move to a fully risk-based pharmacy quality audit framework. The framework now includes two main types of audit.

  • Full pharmacy quality audit – an audit assessing all services provided from the premises. It may include up to 67 criteria. At least 15 working days’ notice are given prior to the audit.
  • Standard inspection audit – a shorter audit focussing on the 10 risk-based criteria (Table 1). These are unannounced audits.

During an audit, the Medsafe auditor assesses each criterion and assigns a rating (ranging from ‘Leading Practice’ through to ‘Unattained Critical’, this being the highest risk).

Information, including the ratings, forms part of the audit framework, and allows Medsafe to monitor pharmacy performance, and to focus resource where further action is needed.

Each quarter, Medsafe updates the pharmacy sector with an overview of current audit trends and findings. The update document is sent to all pharmacies in New Zealand and is hosted on the members’ section of the Pharmaceutical Society of New Zealand’s website. In addition, Medsafe established a sector response group including representatives of the District Health Boards, Pharmacy Council of New Zealand, Pharmaceutical Society of New Zealand, Pharmacy Guild, and other pharmacy sector groups, to provide a forum for discussions of trends identified, and to promote continuous quality improvement in the sector.

Table 1: Risk-based audit criteria (as at August 2019)

Criterion Description
1.02.01 All staff are suitably qualified for the pharmacy services provided from the premises.
2.02.01 There is ready access at the premises to all the required pharmacy equipment.
3.03.02 Appropriate corrective actions are implemented, documented and reviewed contributing to continuous quality improvement.
4.01.02 Controlled drugs requiring storage in a safe, are securely held in an approved controlled drugs safe.
4.01.04 Fridge temperatures are consistently maintained between 2-8°C.
5.01.02 Prescription medicines are supplied in accordance with regulatory and professional requirements.
5.02.01 An approved form of controlled drugs register is appropriately and accurately maintained, and retained on the premises for four years.
5.05.04 Compounding records for individually compounded products are appropriately maintained and stored on the premises for at least three years.
5.07.04 Medicines requiring supply by an accredited pharmacist are recorded, sold and labelled in accordance with regulatory and professional requirements.
5.10.03 Compliance packaging is labelled sufficiently in accordance with regulatory and professional requirements.

Pharmacy quality audit updates: January to March 2019

Medsafe is pleased by the continued trend of improvement in performance in the January to March 2019 quarter. Medsafe looks forward to seeing an increase in the rate of improvement. Community pharmacies are an integral part of the health care system, and thus it is essential that pharmacy practice meets the required standards to contribute to provision of a safe service to patients.

Follow-up inspection audits

Recently Medsafe conducted follow-up inspection audits at pharmacies where high or critical risk had been identified at a previous audit. The follow-up audit only assessed compliance with these criteria. The preliminary findings demonstrated a significant improvement with around two-thirds of the audit criteria found to be fully compliant.

Medsafe acknowledges the significant effort made by many of these pharmacies to raise and sustain their performance.

Medsafe continues to work closely with DHBs, Pharmacy Council of New Zealand, Pharmaceutical Society of New Zealand, and pharmacy sector to help improve performance further.

For any queries regarding the risk-based audit framework of pharmacies, please contact Medicines Control.

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