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Element 3 - Delivery of health programs and services

T3B - What is a Dose Administration Aid?

A DAA is a sealed, tamper-evident device that allows individual medicine doses to be organised according to the prescribed dose schedule.

Note: if the pharmacist provides a non-tamper-evident DAA at a consumer’s request, the service provided must still meet the criteria in the Professional Practice Standard. See also: Definitions.
 
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T3B Action 3.2 - What are the “approved guidelines” for pharmacists providing DAAs?

The approved guidelines are PSA’s ‘Dose Administration Aids Service: guidelines and standards for pharmacists’, the Pharmacy Board of Australia’s ‘Guidelines on Dose Administration Aids and Staged Supply of Dispensed Medicines’ and ‘Standard 7: Dose Administration Aids Service’ within the PSA ‘Professional Practice Standards’.

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T3B Action 7.2 - Who needs to check DAAs prior to supply?

The T3B Dose Administration Aids Checklist Action 1.2 requires ‘Proof that the supplying pharmacist maintains the ultimate professional responsibility (for all aspects of DAA supply) through the DAA log’. 

Each pharmacy needs to determine the checking system they use to maintain accuracy and consumer safety in the provision of dose administration aids supplied by their pharmacy. This system will be described in the pharmacy’s DAA procedure, and evidence in records such as endorsement of the DAA log.

Pharmacists should also be familiar with key references such as the Pharmacy Board Guidelines which further articulate a pharmacist’s professional responsibilities.. 
 
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T3B Action 7.2 - What are the labelling requirements for DAAs?

 

T3B Action 7.2 requires an accredited pharmacy to maintain and follow a procedure for packing DAAs.

The ‘evidence required’ in T3B Dose Administration Aids Checklist provides guidance on what evidence will meet this requirement, considering the pharmacy’s legal and professional obligations [see also: Element 1]. Consistent with this requirement, legal requirements, Pharmacy Board of Australia guidelines and the PSA Professional Practice Standards, the label of a DAA must include:

  • Pharmacy name, address and phone number
  • Consumer name
  • Active ingredients and/or brand name
  • Directions for use
  • Date of anticipated commencement
  • Typical characteristics of each medicine (such as shape and/or colour)

There must also be consideration for how ancillary labels may be applied to a DAA.

T3B Action 8.1d - There is a requirement for the DAA recording system to include “A log of all DAAs packed, endorsed by the pharmacist”. What does this mean?

The pharmacist must endorse a log of DAAs that enables all the DAAs packed to be traced.
The identification of a DAA is usually done by consumer and date, although other reference systems may be used. Unless the log with only the Residential Care Facility listed refers to another list with separate DAAs, then it does not meet the DAA checklist requirement.

The pharmacy should be able to answer the question “Was Mrs Jones’ DAA for next week packed, checked and delivered?” Just because Mrs Jones is at ABC Care does not mean her DAA was packed.

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T3B and T3G - Is a contract required for the delivery of DAAs to a residential care facility?

No.
There is no requirement for a contract between the pharmacy and the care facility specifically for the supply of DAAs. However, if the pharmacy is offering Services to Residential Care Facilities then there is a requirement for a contract in the T3G Checklist.

While not a specific requirement, a contract is strongly recommended to clearly outline the responsibilities of both the pharmacy and the residential care facility.

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T3G - What services are considered T3G Services to Residential Care Facilities Checklist?

The services related to T3G are generally associated with promoting quality use of medicines. This often includes:
  • Pharmacist’s visits to the facility
  • Quality use of medicine education to facility staff
  • Reviews of consumer requirements
  • Maintaining a separate storage of scheduled medicines etc. 
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T3G - What needs to be in contracts between the pharmacy and a residential care facility?

While T3G Services to Residential Care Facilities Checklist mandates a contract between the pharmacy and the residential care facility, the content of the contract needs to be determined between the pharmacy and the facility. Some recommendations for content are included in the checklist.

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T3G - Does a pharmacy who only packs DAA's for a residential care facility have to comply with the T3G Services to Residential Care Facilities Checklist?

No. If the pharmacy only packs DAA's for a residential care facility, they are only required to meet the T3B Dose Administration Aids Checklist.

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T3I and T3C - Is the measurement of clinical indicators (e.g. blood pressure, blood glucose, cholesterol) alone considered to be a Disease State Management or Screening and Risk Assessment Service?

No.
Disease State Management and Screening/Risk Assessment are defined in the PSA Professional Practice Standards and described by the relevant PSA Standard and QCPP’s related checklists. These services are ‘more than just a test’; they involve providing meaningful information to consumers about what the results mean for their health and recommendations for the consumer. 

Both screening and risk assessment and disease statement management services require the pharmacy to record in addition to the measurement or risk score identified, key features of any explanation or summary of key points discussed, and reference to planned or recommended follow ups.

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T2F and T3I - Is daily distribution of medicines via staged supply considered to be disease state management?

No.
As outlined in the definitions, disease state management services are broader than the supply of medicines to manage a health condition. Disease state management is an ongoing process which enhances a consumer’s management of their health conditions. Disease state management services must be within the scope of the definition and the requirements of T3I Disease State Management Checklist.

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Element 3 and All of Program - How long does a pharmacy need to maintain records for the delivery of health programs and services?

QCPP requires pharmacies to maintain their records for a full accreditation cycle, which is 2 years.
Exception: T3F Medication Management Review Checklist and T3K In-Pharmacy Medicine Review Checklist requires records be securely maintained for 7 years.

PPI Programme Specific Guidelines require records to be maintained for 2 years from the time of lodgment of a PPI claim or declaration. For further information refer to ‘Audit Requirements’ in the PPI Program Specific Guidelines available at http://6cpa.com.au/.

The pharmacy may decide to retain records for an extended period of time for professional, legal or other purposes. This is outside the scope of QCPP and further advice on general records retention and management can be obtained from the Australian Records Retention Manual.

Element 2 and 3 programs and services (excluding T3H Health Promotion). If a pharmacy has developed and achieved all the requirements of a health service or program, although no consumers are in need of the service or program (thus evidence of documentation may not be available), how will the health service or program be assessed?


 

QCPP assesses a pharmacy’s quality management system. At the time of QCPP assessment if the pharmacy demonstrates that suitable customers have not been requiring the service or program, and the pharmacy has reviewed their procedures, maintained their training, equipment and resources, and the service remains available to consumers; the service will be assessed in accordance with the relevant requirements, and ensure the recording system meets the requirements.
If the recording system requirements are met the pharmacy will be deemed compliant and the assessor will provide notation within the assessment process that consumers had not required the program or service.
Pharmacies should be aware for Community Pharmacy Agreement incentive payment eligibility, records of program or service delivery maybe individually audited externally to QCPP.

Relevant Element 3 Checklists Action 3 - What are the requirements of the consultation area (excluding vaccination services T3M)?

A consultation area is used in the provision of various health programs and services.
The QCPP Requirements Manual has multiple references to consultation areas:
  • Element 5 Action 3
  • QCPP Definitions and Abbreviations
  • T5A Pharmacy Appearance Checklist
  • T3I Disease State Management Service Checklist Action 6.1
  • T3K In-Pharmacy Medicine Review Checklist Action 6.1
  • T3L Absence from Work Certificate Checklist Action 6.1
The requirements of the consultation area differ slightly between services and guidance outlined in the checklist for each service. The consultation area must:
  • Allow for confidential consultations between the pharmacist and consumer
  • Allows the pharmacist and consumer to talk at normal speaking volumes without being overheard by other pharmacy visitors or staff (screens such as walls, other physical barriers or soft music may be used to enhance privacy)
  • Be neat, clean and hazard free
  • Must not be located in the dispensary or in a location accessible through the dispensary where consumers have access to Pharmacist Only Medicines (S3), Prescription Only Medicines (S4) or Controlled Drugs (S8).
  • Must not be located where stock is unpacked, sorted or other administrative pharmacy duties or services are carried out that may breach pharmacy or patient confidentiality. An example of this is in an area where DAA’s are kept or in the managers or stock controller's office. An exclusion to this will only be provided if the area is set up specifically for counselling only.
  • Ideally, food and drink are not consumed within the consultation area.
For most services, the availability of seating is not required but is recommended. The following checklists provide guidance that the consultation area has seating for available:
  • T3I Disease State Management Service Checklist.
  • T3K In-Pharmacy Medicine Review Checklist.
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Element 3 Action 2 - A number of checklists require “proof of access” to various reference materials. What constitutes “proof of access”?

The pharmacy may elect to use web based products, store links in the favorites (or similar) on a web browser, store electronic copies or maintain hard copy material.
Access to relevant reference material can be through a variety of means. The overriding requirement is that the reference material must be maintained by the pharmacy, not require an individual’s personal membership to access (e.g. members’ only access to PSA documents), not stored on an individual’s personal device or require individual knowledge to access via a web search (e.g. Google search is not adequate as this relies on an individual’s knowledge of what to search for).

Element 3 Action 5 and Element 3 Checklists Action 8.1 - Where recording systems are required for health programs and services, what form can these systems take?

Recording systems can be in electronic format where records are kept in a computer system or in consumer or program files that are in hard copy paper files, journals, diaries or logbooks. These records must contain the mandatory elements needed for each specific health program or service. Mandatory elements can be found in the relevant Checklist Templates in the QCPP manual.

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Element 3 Checklists Action 4.1 - What are the requirements for disposal containers used in the delivery of health programs and services?

Requirements include:
  • Appropriate container with appropriate warning labels for sharps
  • Appropriate container for clinical waste and container disposed of appropriately
  • Above containers to be located where they cannot be easily accessed by unsupervised children
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Element 3 Action 3, T3C and T3I - What protective equipment is needed in the delivery of health programs and services?

Protective equipment needed to deliver health programs and services will depend on the nature of the program and the procedure for each program. Common equipment used includes, but is not limited to, disposable gloves, masks and goggles.
Programs that involve skin penetration and exposure to bodily fluids will need to follow infection control protocols. There are specific requirements for infection control where skin penetration occurs in T3C Screening/Risk Assessment Checklist Action 7.3.

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T3A Action 8.1a - Does the photo of a client have to be legible or recognisable to comply with T3A Opioid substitution Checklist?

Yes. A photo must be legible and recognisable to meet QCPP requirements, state and territory legislative requirements and medication safety principles. The purpose of a photo is to assist a pharmacist in correctly identifying a client at the time of dosing. This may require a photo to be updated over time as a person's appearance changes. Photos may be black and white or colour - either is permissible as long as the photo allows for the clear identification of the client.

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T3A Action 3.1 - What are the training requirements for Opioid Substitution?

The minimum training requirements for all pharmacists involved in an opioid substitution program is proof they have read and understand the pharmacy’s policy and/or procedures. In addition, as indicated through the completion of the T1A Form, the pharmacy should also be aware of and adhere to any jurisdictional legislation or health department requirements surrounding initial and ongoing pharmacist training. All training should be documented on the pharmacists’ T15B Training Record or sighted as a certificate or confirmation from the appropriate state health department or the pharmacists’ CPD log.

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T3A Action 4.3 - Are Subutex (buprenorphine) blister-packs and/or Suboxone (buprenorphine/naloxone) foil sachets considered to be child-resistant packaging as required by T3A Action 4.3?

Yes.
The medicine sponsor (i.e. manufacturer) of products containing buprenorphine is required to comply with ‘Therapeutic Goods Order No. 80 Child-resistant packaging requirements for medicines’. As such, takeaway doses of Subutex and Suboxone supplied in their proprietary packaging (i.e. blister-pack or foil-sachet) are deemed to be contained in “child resistant packaging”.

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T3A Action 4.4.1 - What is meant by ‘sufficient size’ in relation to the drug safe in T3A Opioid Substitution Checklist?

Action 4.4 requires the drug safe to be large enough to store the Controlled Drugs held by the pharmacy, including Controlled Drugs used in the opioid substitution program. If the opioid substitution dosage device is large and intended/or practice is, to stay on the original container until the container is emptied, then the container and device shall be able to be stored in the drug safe. If in doubt the Assessor will ask for a demonstration that the medicine can be stored in the safe.
Assessors do not assess whether the safe meets legal/regulatory requirements of state and territory jurisdictions.

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T3A Action 4.4.2 - Is it mandatory to store the opioid substitution dosage device on the original container in the drug safe?

No. If it is practice for the pharmacy to remove the dosage device from the original container prior to storage in the safe, then the pharmacy must be able to describe their procedure for cleaning of the measuring device. Consideration should be made for ensuring hygiene of the device prior to and after attaching to the original container.

T3A Action 6.2 - The T3A template requires the person receiving the dose has access to drinking water. How accessible should the water be?

The drinking water shall be available free of charge and accessible without requiring the person to move from the immediate counselling area. A glass/cup of water provided separately with the dose is permissible.

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T3C Scope - Do health kiosks count as risk screening services?

As a single entity, health kiosks do not meet the definition and requirements for a screening and risk assessment service. However, if the kiosk is used in conjunction with a direct face to face consultation (and the pharmacy meets all the other requirements of Checklist T3C including having the health kiosk as part of the pharmacy’s procedure and the pharmacy is recording all of the mandatory items, then this may be considered a screening and risk assessment service. 

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T3C and T3I Action 4.1 - What does ensure all equipment used and is listed on the Australian Register of Therapeutic Goods mean?

To comply with Australian regulatory requirements, all therapeutic devices must be registered with the TGA. Registered therapeutic devices are included on the Australian Register of Therapeutic Goods (ARTG) and given an ARTG number.
The ARTG number is not required by any labelling requirements to be on the product or packaging of medical devices. To check a product has an ARTG number, the pharmacy should look up the sponsor/product on the public viewing area of the TGA website, or contact the supplier directly to obtain the ARTG number. 
As evidence for QCPP Assessment, the pharmacy can print out the relevant entry from the TGA website or simply show the Assessor the entry on the website on the day of the assessment (you may also opt to print this webpage out in advance to facilitate the assessment process). 
Although it is acknowledged the ARTG website can be difficult to navigate, the Assessor must be satisfied the pharmacy has made reasonable attempt to obtain the ARTG number and if they continue to be unsuccessful in accessing the ARTG number, a concession may be applied following a successful Remedial Review Request.

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T3C and T3I Actions 5.1, 5.2 - Does a pharmacy need to calibrate an electronic blood pressure monitor?

The equipment needs to be calibrated and maintained in accordance with the manufacturer’s recommendations.
Many electronic blood pressure monitors self-calibrate prior to use, and will return an error message if the calibration is unsuccessful. Unless specifically stated in the blood pressure monitor instructions, there is no requirement to manually calibrate the BP monitor.

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T3C and T3I Actions 5.1, 5.2 - Does a pharmacy need to maintain an electronic blood pressure monitor?

Yes.
A pharmacy must maintain equipment used, including blood pressure monitors.
Manufacturer information on how to maintain the device should be followed. Maintenance could include changing the battery, removing the battery after use (when not intended to be used again for prolonged periods).

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T3C Action 7.1 - Do I need to have a separate procedure for each risk assessment and/or screening service? For example, a diabetes and cardiovascular risk assessment service may include blood pressure readings, BGL readings, cholesterol readings, and weight and height measurements?

No. Pharmacies should create procedures which are appropriate for the design of their service. Screening and risk assessment services for multiple conditions can exist in a combined procedure. Pharmacies should however note this may increase complexity through additional comorbidities and common health risks.

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T3C and T3I Action 7.1 - Is written consent required from consumers when offering screening and risk assessment services and disease state management services?

No. Guidance Action 7.1c of T3C Screening and Risk Assessment Checklist and Action 7.1c of T3I Disease State Management Service Checklist relates to consumer consent for the service, which may be verbal consent or implied consent, The pharmacy must follow the consent process as documented within their customised procedure for the service(s) being provided. 

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T3C - How do training requirements apply to pharmacy interns? (e.g. do pharmacy interns have to do blood pressure training?)

Pharmacy interns are pharmacists, with a restriction on their practice that they must be supervised. As such, the training requirements of a pharmacy intern are considered the same as a pharmacist.

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T3E - What evidence is required to meet the T3E Smoking Cessation Service Checklist requirement for staff training?

Pharmacies need to train all staff involved in the Smoking Cessation Service on their procedure for delivering a Smoking Cessation Service. The evidence required is a T15B Training Record showing training has been completed.

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T3F - Action 2.1 - What proof is required to show that pharmacists involved in a HMR process maintain appropriate accreditation?

The accredited pharmacist needs to have a copy of their current accreditation certificate at the pharmacy for the Assessor to sight. Accreditation certificates are issued annually and are inclusive of expiry dates. Sighting a web search listing is not considered adequate evidence to meet this requirement.

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T3F Action 2.1 - What evidence of pharmacist accreditation is needed for training and qualifications for HMR?

If the pharmacist is an employee of the pharmacy, then all the usual Personnel Records, including a copy of their current accreditation certificate, must be developed and maintained.
If the pharmacist is a contractor, then only a copy of their current accreditation certificate, issued by an authorised accrediting body such as AACP or SHPA, is required.

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T3F Action 2.2 - Medication Management Review Checklist Action 2.2 refers to "an approved communications module". What is this?

Currently the only approved communication module is:
  • Module and 12 question MCQ assessment available on the AACP website.
For pharmacists who have undergone the process of accreditation with AACP in recent years, completing this communications module has been mandatory part of the accreditation process.  The course can also be accessed in a single module by contacting AACP. A training record showing successful completion of this module may be used as evidence for meeting this requirement at QCPP Assessment.

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T3F Action 8.3 - Checklist T3F requires “Proof there is a medication profile”. What information is required as part of the medication profile?

A patient medication profile must contain all mandatory fields included in Action 8.3 (8.3a –8.3i) as part of the records for each patient.

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T3F Action 8.4 - How will the Assessor check the requirement in T3F Action 8.4 “Proof that records are maintained secure and capable of storage for seven years”?

The Assessor may ask for access to the HMR and RMMR reports, and ask questions in relation to the security and duration of storage. If records are stored electronically, then the Assessor may ask the pharmacy to provide access or demonstrate access to these electronic records.
Note: Pharmacies are responsible for maintaining compliance with legal, professional and contractual requirements (e.g. Community Pharmacy Agreement Program Specific Guidelines) in relation to HMR and RMMR records management. These are not specifically assessed by your Assessor.

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T3G Action 8.3 - How can T3G Action 8.3: 'Proof there are contracts for each facility serviced' be demonstrated?

The pharmacy can present a written and signed contract for each facility serviced.

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T3H Scope - Are you providing a health promotion?

“Health Promotion” is defined in the Definitions section of Knowledge Hub.
Health promotion must actively engage consumers at a population or group level.
Health promotion topics may include, but are not limited to: 
  • Promoting health awareness campaigns
  • Promoting health issues such as osteoporosis / SIDS (via Red Nose Day etc.)
  • Promoting screening in conjunction with a health issue i.e Heart Week / blood pressure tests.
  • Promoting the benefits of the electronic myHealth Records in assisting consumers in managing their own health conditions to improve their health outcomes.
Advertising which promotes specific services or a product on sale alone would generally not fall within the scope of health promotion. Health promotion must be planned and comply with the requirements of T3H Health Promotion Checklist.

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T3I Action 2.1 - What is required training for pharmacists when disease state management service(s) is/are offered?

The pharmacist can determine the training that is relevant to the provision of the primary health care service to be delivered. Education of the policy and procedure would be considered appropriate training to be recorded on the training record.

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T3K - Does a pharmacy need to provide evidence of having completed a Medscheck for the pharmacy to be assessed as compliant against T3K In-Pharmacy Medicine Review Checklist?

No.
In the event the pharmacy has the system, procedures and ability to offer the QCPP compliant service but has not had consumers wishing to access this service or are eligible for this service, the pharmacy should still be assessed and if appropriate, deemed compliant. However, if the pharmacy has undertaken a Medscheck, then records should be sighted as outlined in T3K Action 8.1.
The scope of T3K In-Pharmacy Medicine Review Checklist is not limited to MedsCheck, but could also include any other in-pharmacy medicine review service offered by the pharmacy, including consumer funded services.

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T3K - Can a pharmacy create their own recording form for the professional programs and services offered within the pharmacy?

Yes. QCPP does not mandate what documentation system or templates pharmacies should use. All pharmacies including those who create and use their own form for recording, must include all the mandatory fields contained in the applicable professional program/service Checklist located in their QCPP Requirements Manual.
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Do I need to have at least two pharmacists rostered on to undertake In-Pharmacy Medicines Reviews (e.g. MedsChecks)?

No, however the pharmacist resources provided during times consultations occur must be adequate for the pharmacy’s operations. 

Action 1.1 in T3K In-Pharmacy Medicine Review Checklist requires ‘Proof that there are adequate [personnel] resources to provide the in-pharmacy medicine review service.’  The number of pharmacists considered as ‘adequate resources’ will vary between pharmacies and the nature of the service provided.

For example:

  • If at least two pharmacists were practising; one was responsible for providing MedsChecks, while the other(s) were responsible for dispensing, this would generally be considered adequate;
  • if a pharmacist were responsible for dispensing a large number of prescriptions at the same time as trying to provide a MedsCheck service, this would not be considered adequate; and,
  • if a pharmacist scheduled a MedsCheck service during a very quiet period in the pharmacy where few prescriptions are dispensed, this may be considered adequate. 

The intent of the requirement is that consumers are able to be provided with an uninterrupted consultation when discussing their medicines. On the day of assessment, the pharmacy should be able to demonstrate how the personnel resourcing dedicated to the in-pharmacy medicine review service is adequate. The assessor will consider whether the explanation and evidence provided demonstrates resources are adequate.

 

Pharmacies should remain aware of their obligations described in Program Rules for in-pharmacy medicine review services, such as MedsChecks, as QCPP Assessment does not specifically assess compliance with these requirements.  However, these guidelines may be used to help determine if pharmacist resources for a specific service are adequate

T3M - Is a nurse practitioner suitably qualified to provide a third party vaccination service within a pharmacy?

Yes.The evidence required at assessment is the contract between the suitably qualified person (not employed by the pharmacy) which includes a guarantee of the delivery of their legal and professional obligations.
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T3M - What is an appropriate area to hold a Pharmacy Vaccination Service?

A vaccination service should be held in a formal consultation room within the pharmacy that is:
  • Of adequate size (to conduct the service and ensure a consumer could lie down on the ground if required in an emergency (generally no less than 4m2))
  • Have adequate facilities/equipment to support the service and
  • Products for sale must not be located within the consultation room.
However QCPP recognises not all community pharmacies currently have a consultation room, and will require time to allow refurbishment to implement a consultation room. Therefore an appropriate screened area may be used for provision of vaccination services (unless your local jurisdictional legislation or regulations prevent this from occurring).
The screened area must be located within the pharmacy, (be of adequate size to conduct the service and ensure a consumer could lie down on the ground if required in an emergency (generally no less than 4m2)), screening must be of a formal framed structure, at least 2m in height to ensure privacy is maintained and have adequate facilities/equipment to support the service. Product display units are not an appropriate screening material for this service and products for sale must not be displayed within the screened area.

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T3M - When a vaccination service is provided by a third party provider, what information needs to be included in the third party contract?

If a vaccination service is provided by a third party provider, all mandatory requirements in T3M Vaccination Services in the Pharmacy Checklist must be either sighted in the pharmacy on the day of assessment or clearly stated within the third party contract. A declaration stating this has been undertaken is not permissible evidence for QCPP assessment.

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T3M Action 2.1 requires any practitioner administrating vaccines is appropriately authorised. What evidence do pharmacist need to meet this requirement?

Pharmacist immunisers should provide evidence of completed training, i.e. a certificate from an authorised training provider.

The legislative requirements governing the administration of vaccines differ between States and Territories and the pharmacy must ensure the pharmacist immuniser is authorised to administer the vaccine or vaccines in their specific State or Territory.

T3M 6.1 - In relation to the T3M Vaccination Services in the Pharmacy Checklist, do QCPP requirements mandate a bed be present in the area which vaccination occurs?


No.

T3M Action 6.1(a) requires vaccination services to be provided in a screened area where there is adequate room to conduct the service and ensure a consumer could lie down on the ground if required in an emergency.

There is no specific QCPP requirement to provide a bed or mattress. However, individual state and territory legislation and guideline requirements must be followed (external to QCPP requirements) as there are differing requirements in each jurisdiction. For example; Victorian and NSW guidelines require a first-aid couch (or similar).
 
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T3M 8.1 - What records does a pharmacy need to keep if a vaccination service is provided by a third party provider?

The pharmacy will need to show evidence that all mandatory information, as outlined in T3M Vaccination Services in the Pharmacy Checklist Action 8.1, has been recorded. A declaration is not permissible evidence to meet this criteria, assessors will be required to sighted evidence that the criteria has been achieved. If all records are documented and maintained by the third party provider, this must be outlined in the contract and include an attachment of the compliant recording tool used. Equally, if records are documented and maintained by a mixture of both parties, the structure of the service must be outlined in the contract and evidence of all recording requirements will need to be sighted on the day of assessment and/or clearly stated within the contract. A copy of the compliant recording tool must also be attached.

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