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Element 5 - Pharmacy premises and equipment

5.1.1 - How often is the pharmacy required to complete the T5A Pharmacy Appearance Checklist?

There is no requirement for the pharmacy to complete the T5A Pharmacy Appearance Checklist. The T5A can be used as a tool to regularly check the appearance of the pharmacy; it is up to the pharmacy how often it is used. The timeframes shown on the checklist are only a guide for pharmacies.

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5.1.2 - The T5A Pharmacy Appearance Checklist requires that the shopfront is healthcare related. What does this mean and how is compliance decided?

The criteria for compliance is based around whether or not a pharmacy premises can be identified as a pharmacy when viewed from the public domain. As a minimum the premises must clearly display the words Chemist or Pharmacy or Drug or part thereof a combined business name within the displayed frontage.

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5.1.3 - The T5A Pharmacy Appearance Checklist has a mandatory requirement that “Product shelf labels are neat and legible”. Does this mean that product shelf labels are mandatory?

No. If a pharmacy does not have product shelf labels, this action would be considered not applicable (as per Program & Assessment Rule 18).

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5.2.1 - Does a pharmacy have to have a Professional Services Area?

Yes, this is a mandatory action.

5.2.2 - Does the pharmacy have to have a sign that states “Professional Services Area?

No, the Professional Services Area does not require a specific sign that states “Professional Services Area”. However, an Assessor will expect to see some signage within the area to indicate that this is an area where professional activities are undertaken. “The Professional Services Area needs to be distinguishable within the pharmacy”. “This can be achieved by appropriate signage (e.g. ‘Professional Services Area’, ‘Dispensary’, ‘Prescriptions’ etc.) and other factors, such as, different fit-out, colour or different floor materials.”

5.2.3 - In a pharmacy that has limited shop space, is it acceptable to keep items such as confectionery or cosmetic promotions on a counter that is located within the Professional Services Area?

No, the ‘Evidence Required at Assessment’ states, ‘Proof products stored in the Professional Services Area exclude non-health related products and services’. Any non-health related products as listed below, are not able to be stored within the area.
  • Perfumes and deodorants
  • Gifts
  • Confectionery
  • Cosmetics/beauty items
  • Veterinary products
  • Travel items
  • Food products
  • Beverages (excluding water)
  • Household cleaning products

5.2.4 - Are products such as Glucojels™, Butter Menthols™, sugar free lollies etc. allowed in the Professional Services Area?

Sometimes there is a fine line between products that purport to provide a therapeutic effect and confectionery. Obvious lines of confectionery such as chocolate bars and sweets are not allowed in the Professional Services Area. However, confectionery lines that purport to offer a mild therapeutic effect such as some “cough lollies” or soothing throat preparations are allowed in the Professional Services Area. Products such as Glucojels™ and sugar free lollies may have some application to diabetic patients and as such are allowed within the Professional Services Area. Other products may not be so easy to classify and therefore the decision will rest with the Assessor at the assessment.

5.2.5 - What are the requirements of the Professional Services Area?

The Professional Services Area is partially defined in a number of areas of the standard, but the full specification is not given. The overall specification is:
  • Distinguishable from the general trading area (Element 5 Action 2) e.g. by a system of signage (Template T2C Action 4)
  • Supervised by a Pharmacist (Element 5 Action 2 and Template T2C Action 6)
  • Includes the dispensary area (Element 5 Action 2)
  • Includes an area for confidential conversations (Element 5 Action 2)
  • Includes a professional trading area (Element 5 Action 2)
  • Excludes non-health related products and services (Element 5 Action 2)
  • Includes all Pharmacy Medicines (Element 8 Action 7 and Template T2C Action 6)
  • Trained pharmacy staff members are visible in the Professional Services Area (Template T2C Action 1)
  • No direct access for consumers to Pharmacist Only Medicines (Template T2C Action 6)
For the purpose of QCPP Accreditation, the definition of Professional Services Area is taken from the Standard (AS85000 Quality Care Pharmacy Standard), which may differ from the interpretation of state/territory regulatory bodies.

It should be noted that there is no requirement for the Professional Services Area to be a regular shape. It is permissible for the shape of the Professional Services Area to be curved or U-shaped; however, it must be a continuous area and not have “holes” in it. For clarity, the storage or retailing of unscheduled medicines and therapeutic goods outside this area is not in conflict with the requirement.

Health related products includes, but is not limited to all medicines (including complementary medicines) and therapeutic devices (e.g. blood pressure monitors)
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5.2.6 - Why does QCPP require the pharmacy to have a Professional Services Area?

The QCPP requirement relating to the Professional Services Area intends to distinguish community pharmacy as a healthcare destination rather than a normal retail environment.
This is particularly important to convey to customers and stakeholders such as government and other health professionals.

The Professional Services Area should contain all scheduled medicines, areas for private consultation, and discreet administration of medicine such as opioid substitution, if provided. Non-pharmacist staff need to be able to be observed in this area to monitor the quality of health advice being provided to customers. Unscheduled medicines and health related products can be stored outside the Professional Services Area. There should not be any non-health related products or services within the Professional Services Area.

There may be jurisdiction legislative requirements regarding storage and access to scheduled medicines over and above the QCPP requirements which pharmacies must be aware of, and comply with.

Example health related products (other than scheduled medicines

Example non-health related products

Vitamins/supplements
Diabetic hypoglycaemia products e.g. Glucogels
Thermometers
First Aid products e.g. bandages
Heat packs
Baby/infant treatments
Screening kits e.g. bowel screening kits, genetic screening kits
Skin care e.g. moisturisers, eczema treatments
Medicated hair care products e.g. anti-dandruff products
SPF rated Sun protection items e.g. hats, sunglasses, rash vests, sunscreen
Medical devices e.g. blood pressure machines, sleep apnoea
Veterinary medicines e.g. worming tablets
Antiperspirants
Sunglasses (Australian Standard AS1067 Category 2 or higher)
 
Perfumes and deodorants
Gifts and toys
Confectionery
Cosmetics/Beauty items
Hair accessories, hair colours and hairsprays
Non-medicated shampoos and conditioners (including dry shampoo)
Clothing items e.g. fashion hats, beanies, fashion sunglasses
Veterinary products e.g. animal food and toys
Travel and electronic items
Food products
Beverages (excluding water)
Household cleaning products
Toilet paper
Hair removal products e.g. waxing strips and creams
Sun tanning products and self-tanning products

This should not be considered an exhaustive list. Any queries regarding permissible products can be sent to interpretations@qcpp.com

5.4.1 - Are all dispensary refrigerators listed on the QCPP Compliant Refrigerator list Cold Chain Testing Centre (CCTC) certified?

QCPP expect that your pharmacy stores temperature sensitive medicines in a purpose-built refrigeration unit that is designed and constructed specifically for therapeutic goods. This includes purpose-built refrigeration units that are integrated within an automated dispensing system.
In addition to CCTC approved refrigerators, the QCPP Compliant Refrigerator list has been expanded to include refrigerators that have been approved to be QCPP compliant, e.g. refrigerators that are ARTG listed

5.5.1 - What pharmacy equipment needs calibration or maintenance?

Any equipment, instrument or test that gives a measurement needs calibration to ensure that the equipment still performs accurately against a standard. Common examples of equipment that need calibration or maintenance in a pharmacy include, but not limited to, scales, blood pressure and glucose monitors. Records of calibration results and maintenance undertaken are to be recorded.
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5.5.2 - How often does the pharmacy need to get equipment calibrated?

The equipment needs to be calibrated and maintained in accordance with the manufacturer’s recommendations. The Assessor will not comment on timeframes but just ensure equipment calibration records show that calibration is occurring as per the pharmacy's schedule.

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5.6.1 - What happens if the pharmacy does not have their Cold Chain Testing Centre certificate at the assessment?

A remedial action will be issued. A cold chain certificate will be required to close the remedial action.

5.6.2 - Does each dispensary refrigerator require a cold chain certificate?

Yes.

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5.6.3 - How long is a Cold Chain Certificate valid?

A Cold Chain Certificate is valid for two years from the date of issue stated on the certificate. On a pharmacy's QCPP assessment day, the Cold Chain Certificate must be current in order to be accepted.

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5.6.4 - Where can a list of approved dispensary refrigerators from the Cold Chain Testing Centre be found?

QCPP maintains a definitive list of QCPP approved dispensary refrigerators; this can be found on the QCPP website.

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5.6.5 - If a pharmacy is using a digital device inside the dispensary refrigerator and downloads the results each month, is the pharmacy still required to complete T5C?

QCPP Element 5 Action 6 requires the pharmacy to provide documented evidence of daily refrigeration checks and compliance with all requirements of T5C. T5C stipulates the pharmacy must record the minimum and maximum temperatures for each day of the month (for all trading days). QCPP Assessment evidence requires that the refrigerator has been checked daily, in which a monthly download is not considered sufficient to meet this criteria.

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5.6.6 - How often should I record min and max refrigerator temperatures?

QCPP requirements state at a minimum, daily recording (Element 5, Action 6). However, pharmacies should remain aware of other guidelines which may suggest more frequent monitoring is required. For example, the National Vaccine Storage Guidelines – Strive for 5, outlines monitoring and recording of vaccine refrigerator temperatures twice daily and after power outages to ensure cold chain is maintained.

5.6.7 - Does a pharmacy dispensary refrigerator have to be certified by the Cold Chain Testing Centre (CCTC)?

No. Effective from 16 July 2018, QCPP will apply concessions on-site during assessment if the pharmacy choose to use a certification service provider other than the CCTC and can confirm the accuracy of the refrigerator temperature through:
  • Evidence that accuracy has been confirmed through a service provided by the refrigerator manufacturer OR
  • Evidence that accuracy has been confirmed through a service provided by an Australian Refrigeration Council (ARC) licenced refrigerator technician.

QCPP understands that the CCTC will continue to offer fee-for-service dispensary refrigerator testing services.

5.6.8 - How often does the pharmacy have to record refrigerator temperatures?

QCPP currently accredits pharmacies against the AS85000:2011 Standard which stipulates once daily monitoring. However, QCPP understands that, consistent with the Australian Government’s Strive for 5 Guidelines, best practice is twice daily manual monitoring. 

Moreover, QCPP is aware that in most states and territories, if your pharmacy is providing a vaccination service, you are expected to adhere to Strive for 5 Guidelines. QCPP recommends.

5.6.9 - Can the pharmacy use automated data loggers instead of manually logging refrigerator temperatures?

No. Consistent with the Australian Government’s Strive for 5 Guidelines, pharmacies must continue to record minimum and maximum temperatures daily, regardless of if a data logger is being used (please refer to the Strive for 5 Guidelines).

5.6.10 – How does the pharmacy carry out refrigerator temperature monitoring if the dispensary refrigerator doesn’t have a visible temperature panel?

Consistent with the Australian Government’s ‘National vaccine storage guidelines – Strive for 5’, pharmacies may use a data logger with a visual display of minimum and maximum temperatures to allow twice daily readings to be viewed and recorded (please refer to the Strive for 5 Guidelines).

5.6.11 – What are the minimum requirements for having an automatic data logger to monitor refrigerator temperatures?

QCPP recognises the increased use of data loggers for monitoring daily refrigerator temperatures. In order to meet current Strive for 5 guidelines for refrigerator monitoring the following data logger features and recording procedures must be followed:

  • A twice daily recording log of minimum and maximum temperatures
  • An acknowledgement log of staff members checking twice daily refrigerator temperatures
  • Real-time capturing and alert system of temperature deviations outside the recommended range
  • Inability to tamper with automatic recording results
  • System for notifying staff members of a power outage that affects fridges

If the data logger does not meet the above requirements; the pharmacy must revert to manual procedures, as per Element 5 Action 6.

5.7.1 - Does every pharmacy require an air-conditioner?

A pharmacy needs to be able to demonstrate that it is able to prevent the temperature from exceeding 25 degrees celsius in the professional services, trading and storage areas. If the pharmacy does not have air-conditioning, they must be able to produce reasonable data to support their claim that the temperature would not exceed 25 degrees celsius throughout the year. This data might include readings from temperature logging devices or local temperature recordings by the Australian Bureau of Meteorology. In the absence of air-conditioning, it is the responsibility of the pharmacy to provide the necessary data.

5.8.1 - How can the pharmacy measure lighting to ensure it is is at least 400 Lux?

A light meter can be used for measuring light in units of Lux.
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5.8.2 - How can a light meter be used?

The requirement relates to the level of lighting throughout the pharmacy. This would include, but not be limited to areas used for the preparation of DAAs, dispensary, compounding area, counselling area, between shelves in the dispensary and in several places around the shop area. A minimum of 400 Lux should exist in all areas.

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5.10.1 - If a pharmacy is located in a shopping centre complex, does this mean the Pharmacist is required to have a key to the complex?

No, it may be that if the Pharmacist requires access, he/she may need to contact centre management or security staff to obtain access.

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