Glossary | QSPP

A

Accreditation: In reference to QSPP, accreditation is a process of review that allows pharmacies to demonstrate their ability to meet requirements and standards established by a recognised accreditation body.

Accreditation cycle: The period that a pharmacy is accredited for from the successful completion of their assessment, in ordinary circumstance this is three years.

Accreditation date: The date from which accreditation is granted.

Accreditation invoice: The annual invoice required for maintenance of accreditation.

Additional assessment

A non-accreditation QSPP assessment conducted by an approved and independent QSPP endorsed assessor. Additional assessments can include:

supplementary assessment - may consist of either onsite or remote documentation assessment. A maximum of two random assessments may be conducted in any calendar year;
unannounced assessment (without notice);
expansion of Services assessment if QSPP is notified, or believes, that the pharmacy business has expanded its service offering which is relevant to their QSPP accreditation;
mid-cycle review – consists of a virtual assessment at the mid-point between accreditation assessments for pharmacies accredited under QSPP;
transition assessment – consists of a virtual assessment for pharmacies who will not undertake their accreditation assessment under QSPP until after March 2028, providing a touchpoint; and
mandatory reassessment – consists of a full onsite assessment for pharmacies who do not meet compliance requirements during a scheduled Assessment or Mid-cycle review.

Administration invoice: A fee to recover administrative costs of QSPP delivering services additional to services included in the accreditation invoice.

Appeals: A request for reversal or re-consideration of a decision made by QSPP.

AS 85000:2024 (Australian Community Pharmacy Standard): Provides guidance for the design, implementation and continuous improvement of a community pharmacy quality management system. QSPP accreditation is granted or denied against the standard.

Aseptic technique: A set of practices aimed at minimising contamination and is particularly used to protect the patient from infection during procedures.

Assessment cancellation fee: The fee incurred if the on-site assessment is cancelled within 10 calendar days of the assessment date.

Assessment period: The commencement date of assessment as agreed between the QSPP assessment provider and the pharmacy.

Assessment results: The outcomes of the conducted assessment as reported to the pharmacy.

Assessor: A person endorsed by QSPP to carry out QSPP Assessments.

Assessor travel invoice: Will be issued where the pharmacy has not accepted the most cost-effective assessment date or has cancelled an assessment and non-refundable travel costs had already been incurred.

Audit tool: The device used by QSPP assessors to conduct the assessment.

Australian Charter of Healthcare Rights: Specifies the key rights of patients and consumers when seeking or receiving healthcare services.

Australian Pharmaceutical Formulary (APF): Mandatory text that guides pharmacy practice in effectively making clinical judgements, identifying drug-related issues, preparing extemporaneous products and counselling on the safe and effective use of medicines.

Authorised attendee: The role of the authorised attendee is to observe and/or validate the assessment approach used by the assessor.

B

Booking confirmation: A confirmation of assessment date and expectations prior to the assessment.

Business continuity plan: A plan to help your pharmacy respond to a crisis event, minimise interruption, recover and resume normal operations as quickly as possible. A crisis event may be a fire, flood, loss of key staff, pandemic etc.

Business governance: The set of relationships and responsibilities established by the pharmacy between its owners, management, staff, and stakeholders (including patients and consumers) to ensure the pharmacy business is viable and sustainable and operates in compliance with relevant laws and regulations.

C

Calibration: A process of ensuring a device reads or takes measurements accurately, in accordance with its manufacturer’s instructions.

Clinical governance: The accountability of pharmacy owners in ensuring that there is a strong culture and appropriate systems and processes in place to support the safety, quality and continuous improvement of all activities and services provided in or from a community pharmacy. It involves relevant and appropriate relationships and responsibilities to be established between pharmacy owners, their staff, patients, consumers, and other stakeholders to support good clinical outcomes for patients. It ensures that community pharmacies and their patients can be confident that systems are in place to deliver safe, quality and patient-centred health care.

Clinical Indicators: Measures of the process, structure and/or outcomes of patient care to identify areas of concern which might require further review or development.

Clinical performance: The ability of pharmacy staff to delivery safe, quality healthcare and achieve appropriate clinical outcomes.

Cold chain management: The system of transporting and storing temperature-sensitive medicines and vaccines, within their defined temperature range at all times, from point of origin (manufacture) to point of administration, to ensure that the integrity of the product is maintained.

Complementary medicines: Include products containing herbs, vitamins, minerals, nutritional supplements, homeopathic medicines, certain aromatherapy products, and traditional Chinese medicines.

Complex Compounding: The preparation and supply of a single 'unit of issue' of a therapeutic product that is intended for supply for a specific patient and that requires or involves special competencies, equipment, processes and facilities. Sterile, cytotoxic, hormone, micro-dose, single-unit dosage forms, sustained-release and modified-release preparations.

Conflict of interest: A situation where a person or an organisation has multiple interests (financial or otherwise) and serving one will adversely affect the other.

Consultation area: An identifiable area or separate room within the professional services area that allows for confidential interactions and conversations at normal speaking volume without being overheard by others.

Consumer: A person who has used, or may potentially use, pharmacy services, or is a carer or family member of a patient using pharmacy services.

Controlled medicines: Schedule 8 medicines; medicines with strict legislative requirements for storage and supply.

Corrective Action Review (CAR): A pharmacy's ability to appeal a corrective action decision made by an assessor by providing evidence to re-consider. Decisions will be based on the evidence presented to the Interpretations and Rulings panel.

Corrective actions: An action that is required to remediate a non-conformance in the Quality Management System.

D

Declaration: An authoritative establishment of fact.

Dispensing: The review of a prescription and the preparation, packaging, labelling, record keeping and transfer of the prescribed medicine including counselling, to a patient, their agent, or another person who is responsible for the administration of the medicine to that patient.

Dose Administration Aids: Dose Administration Aid services include packing of medication packs and sachets for consumers in residential care or the community setting.

E

Evidence-based practice: A process that integrates the best available scientific evidence with professional judgement and patient preferences to make clinical decisions.

Exceptional circumstances: Events that have an immediate impact in the pharmacy’s ability to deliver regular services and where the pharmacy has done all reasonable action to mitigate impact to maintain their reaccreditation (out of the pharmacy’s control).

Expansion of Services Assessment: When a pharmacy seeks provisional accreditation for an additional service from a higher service level between assessments, it must provide evidence of compliance with the higher-level service requirements.

G

General trading area: Location of the pharmacy that excludes the professional services area and usually used for general retail products and sales.

Guidelines: Clincal practice guidelines are systematically developed statements to assist healthcare provider and consumer decisions about appropriae health care for specific circumstances.

H

Hazardous materials: An item or agent, which has the potential to cause harm, whether by itself or with other factors.

Health literacy: Health literacy can be divided into individual health literacy and the health literacy environment. Individual health literacy is the skills, knowledge, motivation, and capacity of a person to access, understand, appraise and apply information to make effective decisions about health and health care and take appropriate action. The health literacy environment is the infrastructure, policies, processes, materials, people, and relationships that make up the health system and have an impact on the way that people access, understand, appraise and apply health-related information and services.

Health promotion: A process/activity where the pharmacy actively engages consumers and the community to promote health and wellbeing at a group or population level.

Healthcare record: A record of a patient’s medical history, treatment notes, observations, correspondence, investigations, test results, prescription records and medication charts for an epiode of care.

I

In-pharmacy medicines review: An in-pharmacy review of a consumer's medicines which focuses on education and self-management e.g. MedsCheck.

Incident: An event or circumstance that resulted, or could have resulted, in unintended or unnecessary harm to a patient or consumer, or a complaint, loss or damage. An incident may also be a near miss.

Incident Management: The actions taken to address an incident and prevent the incident from recurring. These actions may include conducting a root cause analysis to ascertain the cause of the incident, implementing a corrective action to fix the incident, and taking preventative action to ensure the incident does not occur again.

Informed consent: Informed consent is a person’s voluntary decision about healthcare that is made with knowledge and understanding of the benefits and risks involved.

Initial assessment: A pharmacy's first QSPP assessment.

Initial pharmacy: A new pharmacy who has registered for QSPP accreditation.

Intern pharmacist: Pharmacists, with a restriction on their practice that they must be supervised.

J

JASANZ (Joint Accreditation System of Australia and New Zealand): Accredited certification and inspection of products, processes and people.

K

Knowledge Hub: Support and resource material located in the QSPP Customer Portal.

L

Lapsed pharmacy: A pharmacy whose accreditation has expired or has been revoked due to failure to meet one or more of the program rules or requirements.

Lead assessor: An endorsed QSPP assessor responsible for performing a QSPP assessment on a pharmacy. They may be shadowed by another assessor in training or by an authorised attendee to observe and/or validate the assessment approach used by the assessor.

M

Medical device: A health-related instrument, apparatus, appliance, material or other article (whether used alone or in combination and including the software necessary for its proper application) intended to be used for health care.

Medicines: Medicines are therapeutic goods represented to achieve an intended health benefit including all prescription medicines, non-prescription medicines and complementary medicines.

N

Non-conformance: The absence of, or a significant failure to implement and /or maintain conformance to the requirements of the applicable standard or clause.

Non-prescription medicines: Medicines that do not require a prescription to be attained.

O

On-site: An assessment conducted on the pharmacy premise.

Operations manual: The manual prepared as a result of the QSPP Requirements that includes all policies, procedures and templates used in the pharmacy.

Opioid Substitution Program (OSP): A harm minimisation treatment program for opioid dependence offered by the pharmacy, usually in conjunction with a state/territory health program.

P

Patient: A person who is receiving health care from a healthcare service such as a pharmacy.

Patient identifiers: Items of information for use in identification of a patient, including family and given names, date of birth, sex, address, healthcare record number, and individual healthcare identifier.

Pharmacy owner/proprietor: A person, partnership of persons, associations of persons, being an employer and as such carrying on the business and profession of a pharmacist, individually or in a partnership in private practice within the Commonwealth of Australia or its territories.

Policy: A course or principle of action adopted or proposed by an organisation or individual.

Prescribing: An iterative process involving the steps of information gathering, clinical decision making, communication and evaluation which results in the initiation, continuation, or cessation of a medicine.

Procedure: A sequential set of steps which describes a process for doing something.

Professional Service Area: A continuous area established within a pharmacy where only health-related products and services are provided and is supervised by a pharmacist.

Professional Services Declaration (PSD): An electronic form completed by the pharmacy prior to assessment, that indicates the professional services conducted within the pharmacy and that must be assessed to obtain accreditation.

Program rules: A set of QSPP regulative rules that all pharmacies must accept and adhere to, to obtain QSPP accreditation.

Q

QCPP: Quality Care Pharmacy Program

QSPP: Quality & Safety Pharmacy Program

QSPP Customer Portal: An online hub for pharmacies to view and submit evidence, make payments, control pharmacy information and allocations and view important information and resources on assessments.

QSPP Impartiality Sub-Committee: A group of pharmacy industry representatives who discuss all issues relating to QSPP and formulate rulings to ensure that the program remains impartial to all pharmacies.

QSPP Logo: The logo as defined in the current edition of the QSPP style guide.

Quality Care 2020 (QC2020): Quality Care 2020 program is the edition of the QCPP program commenced on 1 October 2020 complying with the Australian Standard 85000:2017.

Quality management system (QMS): A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organisation’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

R

Re-accreditation: When an already accredited pharmacy must undertake their next onsite assessment in line with the accreditation cycle, to maintain accreditation.

Return to program: Pharmacies who were once accredited under QCPP or QSPP and wish to return to the program.

Revoking or suspending accreditation: Temporary or permanent cancellation of QSPP accreditation due to critical breach of the QSPP rules.

Risk: The chance of something happening that will have an negative impact. Risk is measured by the consequences of an event and its likelihood.

Risk assessment: Assessment, analysis and management of risks. It involves recognising which events may lead to harm in the future and minimising their likelihood and consequences.

Risk management: The design and implementation of a program to identify and avoid or minimise risks to patients, employees, volunteers, visitors and the organsation.

RUM Container: A specialist container approved by the Return of Unwanted Medicines Project and used to store unwanted medicines returned to a pharmacy.

S

Sampling: Randomly selected questions from the total population.

Sanction: Disciplinary action against a pharmacy deemed to be in breach of the program rules, terms and conditions.

Scope of practice (of a pharmacist): A time-sensitive, dynamic aspect of practice which indicates those professional activities that a pharmacist is educated, competent and authorised to perform and for which they are accountable.

Self-assessment: Self-Assessment or 1st Party - An internal assessment /audit that an organisation performs on itself.

Senior assessor: An EY employee who has been endorsed as a QSPP assessor and their primary role within the firm is to perform QSPP assessments only, e.g. on a full-time basis.

Simple compounding: The preparation and supply of a single 'unit of issue' of a therapeutic product intended for a specific person in response to an identified need. It involves extemporaneous dispensing from formulations published in reputable references, such as the APF, and formulations for which information confirming quality, safety, efficacy and rationality is available and excludes preparations or sterile products.

Supply of medicines: The provision of medicines within a pharmacy environment and includes prescriptions from a health professional or by request from a consumer and covers the assessment of the consumer’s requirements and the provision of professional advice.

System: The resources, policies, processes and procedures that are organised, integrated, regulated and administered to accomplish a stated goal.

T

TGA: Therapeutic Goods Administration

Therapeutic goods: Goods that are represented in any way to be, or that a likely to be taken for therapeutic use or used as an ingredient or component in the manufacture of therapeutic goods.

Training and development record: A record of training and/or development activities for each employee, including details such as dates, duration and learning objectives.

Training plan: A documented training and development plan for employees which helps identify and undertake activities to meet their professional development needs or skill required for their role.

W

Witness assessment: An observational assessment that seeks to enhance the awareness of QSPP Assessment processes and meet any additional requirements such as JASANZ accreditation. Witness Assessments are conducted by both QSPP and EY.