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An evaluation of the Quality Care Pharmacy Program Final Report

Consortium: ACPPM,QMC, UQTRU February 2005 19

3. DEVELOPMENT AND HISTORY OF QCPP 3.1 CHAPTER SUMMARY Conceptualisation and key stakeholders The program was conceived in 1996–97 as a method of improving pharmacy service standards overall, triggered by the erosion of pharmacy share of health and beauty retail and by consumer data that showed an inconsistency of service and retail offering across community pharmacy. Once planning for the program commenced, the need for professional standards was rapidly identified and the Pharmaceutical Society of Australia developed an initial set of standards, based on their own Professional Standards, but formatted to ‘fit’ with the style of the other program standards. Whilst program design remained within the control of an administratively-efficient working group, there was wide stakeholder consultation across all areas of the pharmacy industry. Development of standards The standards were grouped into two areas: Pharmacy Standards and Team Standards. Standards (other than the Professional Standards which were part of the pharmacy standards) were developed by the consultants for the project, the CR Group, in consultation with the administrative committee and wider industry stakeholders. This consultation process was both substantially inclusive and iterative. Roll-out of Program The program was ‘launched’ to the industry at the Australian Pharmacy Professional event in March 1998. Subsequent of that launch commitments were received from pharmacy wholesalers in respect of their banners/brands and by May 1998, 2325 pharmacies had registered for the program. The ‘slow’ uptake by community pharmacy (both registrations and accreditation) saw the introduction of financial incentives in October 2000 as part of the Third Community Pharmacy Agreement. These incentives, available both for registration, accreditation and subsequent reaccreditation, have resulted in 98.3% of eligible pharmacies being currently registered with the program and 88% of eligible pharmacies being currently accredited. Maintenance of standards Although maintenance of standards might, in theory, be possible on an individual basis, and self-assessment is indeed part of the program, a system of external assessment has been maintained. This is achieved both by regular reaccreditation on a three-yearly basis, and by the work of the Quality Care Pharmacy Support Centre and their Standards Maintenance Assessment (SMA) visits. The SMA visits not only include an assessment of the extent to which the subject pharmacy follows the professional standards in respect of one of a number of standardised scenarios, but also allows for ‘remedial’ training where the pharmacy’s performance has been less than ideal. Performance against other standards is also examined during the visits. Continuous quality improvement The program currently includes a standard dealing with the implementation of continuous quality improvement in the accredited pharmacy. Whilst not strictly



conceptually correct (CQI is a way of doing things all the time rather than a separate process to be complied with), this approach is nonetheless appropriate as a means of introducing the concept to community pharmacies. We comment throughout this evaluation on the difficulties associated with the introduction of quality concepts across an individual organisation and note that, given these acknowledged difficulties, the difficulty in implementing both a consistent application of standards and a quality culture across some 5000 individual entities is greatly magnified. In this context, it is our view that the design (including the consultative process), implementation (including the launch process, implementation, incentivisation and maintenance of accreditation) have been implemented exceptionally well, notwithstanding our comments inter alia, as regards improvements.

3.2 CONCEPTION AND DEVELOPMENT OF QCPP The data informing the history and origins of QCPP was compiled using interviews with key stakeholders and from program files. Files on hand in the Pharmacy Guild of Australia (Guild) National Secretariat in Canberra were scrutinised and interviews were conducted with QCPP staff in the National Secretariat. Other ‘core’ stakeholders were interviewed and included the Pharmaceutical Society of Australia (the Society) (Mr Jay Hooper) and the Department of Health and Ageing (the Department) (Dr John Primrose) and a Guild Official (Mr Kos Sclavos). Comments and insights from these interviews were added to those gathered from the QCPP files. All files were examined on a sequential or time-series basis. The flow of events throughout a particular file was inspected, noted and then placed in the overall context of the particular question being addressed and the totality of the program development. Clarification was sought from QCPP staff on aspects of the administration, in particular those relating to the construction, use and interpretation of the QCPP database. The evaluators were also given access to various PSA documents and reports, including some minutes of meetings and file notes held by Jay Hooper. A timeline representation of the development of the program, implementation and ‘milestone dates’ is shown in Figure 3.1.

3.2.1 KEY STAKEHOLDERS AND FACTORS THAT INFLUENCED THE DEVELOPMENT OF QCPP

The concept of a quality care program in pharmacy was a response to the decline in retail or ‘front of shop’ business within Australian community pharmacy. The Guild discussed the issue with a consulting firm, CR Group, in March 1996 and the CR Groups responded with a proposal to conduct a workshop dealing with the ‘Future of Community Pharmacy’. The files show that the genesis of the concepts of standards or, indeed, the need for pharmacy to ‘lift its game’ arose from discussions between the Guild and the CR Group in March 1996, and this formed the basis of a CR Group proposal of 1 April 1996 for a workshop, broadly dealing with the ‘Future of Community Pharmacy’. The first page of this proposal noted, “..the future of retail pharmacy will



ultimately be decided not by the industry nor by the Government, but by customers” 6. This workshop was held in Melbourne on 3 March 1997 and was attended by key representatives from the Guild, PSA, universities, pharmacy wholesalers, pharmacy boards, state and federal health departments, and pharmacy business managers and accountants.

3.2.2 SETTING THE GOAL

The following excerpt is from the QCPP website.7 It is the only discoverable statement of the strategy and goals of the program as propounded by the program itself:

“In 1997, The Pharmacy Guild of Australia saw a need to protect and expand their members’ front-of-shop business to ensure their future viability in an environment of ever increasing competition. The Pharmacy Guild of Australia subsequently developed a business model that covered standards for all retail services as well as standards relating to business practices. The aim was to create a quality assurance program dedicated to raising the standards of service given to the public as well as improving profitability. This led to the development of the Quality Care Pharmacy Program (QCPP). As a result of competition policy developments, the Guild decided to expand the business model to include professional practice standards. The aim had thus moved from purely a business model to a quality assurance program dedicated to raising the standards of service given to the public, to improving health outcomes, as well as improving profitability. In March 1998, the QCPP was launched to the industry at the Australian Pharmacy Professional conference on the Gold Coast in Queensland.”

3.2.3 RESISTANCE TO CHANGE

Sources of organisational resistance might have applied at both representative organisational level (The Pharmacy Guild, The Pharmaceutical Society and at the ‘representative’ level of the banner/brand groups), and further at the organisational level of each pharmacy. Individual resistance to change would be expected to operate at the level of the community pharmacy but also at the representative level. The following comment, whilst not typical, is illuminating. “…(it) understands the that the real purpose of the Standards was to show the Government that we are committed to self-regulation and that the Guild is doing its best to promulgate this. Hence the standards should not become anything more than industry guidelines”8. Resistance to change certainly occurred at the individual level with numerous findings from focus groups, reviews and the pharmacy surveys citing a ‘lack of time’ or ‘too busy’ as a prime reason for lack of progress and these are discussed further in section 5.2.2.4. p169.

6 Kelly C. letter of 1 April 1996 in PGA File Series (330) CR Group and pharmacy 2000: future directions for community pharmacy 7 Bridge G. About QCPP. [web] 1998.[access accessed 13 December 2004]<http://www.qcpp.com/about_QCPP.htm> 8 Tasmanian Branch Committee PGA letter to S Greenwood.3 April 1998. PGA File Series (383):The Quality Care Pharmacy Program Committee.


Consortium: ACPPM, QMC, UQTRU February 2005 22

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Figure 3.1 Timeline of significant events for QCPP



The workshop was followed by a plenary session at the Australian Pharmacy Professional (APP) on 7 March 1997 focusing on ‘Achieving Service Quality in Retail Pharmacy’. The attendees at the APP included community pharmacists, pharmacy wholesalers and retailers, pharmacy professional organisations, government representatives and pharmacy press. The importance of consumer’s wants, needs and demographics was considered the biggest challenge facing pharmacy market place relevance. Pharmacies were grappling with issues related to: Lack of differentiation Wide variances in performance No common view of consumer expectations Large variances in consumer service Competitive pressure on margins Lack of consumer loyalty Low staff morale.

The CR Group presented at the conference and outlined a proposal for strategies to protect and enhance the future viability of community pharmacy beyond 2000. The slides from this presentation are germane to the original concept and the extent of its implementation. The presenter, Chris Kelly of the CR Group, outlined a proposal for ‘Achieving Service Quality in Retail Pharmacy’ (effectively the ‘outcome’ of the March 3 workshop) to a plenary session at the Australian Pharmacy Professional Conference entitled ‘The Future of Pharmacy –Leading Edge Retailing’ on March 7 1997. The CR Group proposed the development of a set of retail standards to improve consistency and quality of community pharmacy services in the front of shop and to “… identify potential pathways (formats, channels, approaches) that can protect and enhance the future viability of community pharmacy beyond 2000” 9. In the view of the CR Group, these issues facing pharmacy were symptoms not causes and they further observed that “most companies seek the answers to strong, sustainable performance in the wrong places: viz. New image of standards (our emphasis) Cost reduction New product development or branding initiatives. Topical, tactical solutions e.g. increasing the advertising spend and training and

noted ‘in isolation, none of these guarantee future performance”. This summarised to their view that “differentiation doesn’t mean merely being different, It means ‘defining, occupying and exploiting a strategic portion in the retail marketplace’ and ‘being significantly more attractive than competing stores to your target consumers and requires coordination of business risk in support of that positioning – marketing and sales, layout, pricing, consumer service, merchandising, inventory etc”.

9 Kelly C. Achieving service quality in retail pharmacy. PGA File Series (330) CR Group and pharmacy 2000: future directions for community pharmacy



Figures for ‘average pharmacy performance’ (1984/85 compared to 1994/95) were also shown. Some performance figures of interest are shown in Table 3.1.

Table 3.1 Average gross margin (total) and sources of sales in pharmacies. 1984-85 and 1994-95

Selected performance indicators 1984/85 1994/95 Average Pharmacy margin (GP%) 37.0% 33.8% % Dispensary Sales (to total sales) 44.3% 61.6%

Further they observed that retail pharmacy was “fragmented, with no recognised leader, over-shopped, that there was competition essentially between pharmacies only (rather than channel competition), there was a lack of retail and marketing acumen and that pharmacy was a commodity product” (our emphasis). They also noted features of resistance to change and a “bunker mentality” from pharmacists who “tend to believe they service consumers better than they actually do”. As the work of community pharmacy incorporates both retail and professional elements, the need for both retail and professional standards for community pharmacy was evident. The Executive Committees of the PSA and the Guild met at APP 1997 to discuss the development of pharmacy standards and this meeting laid the foundation for future cooperation in the development of a quality program with professional and business standards. The timeliness of this move by the Guild can further be seen by reference to a press release from the Minister for Small Business and Consumer Affairs on July 9 1997, detailing the Commonwealth’s aim to have “service charters” in place within two years with a view to “determining the quality of service expected by the community”. 10

3.2.4 DEVELOPMENT OF STANDARDS

3.2.4.1 Development of retail standards

To address the issues facing the retail aspects of providing a health services and products, the CR Group proposed that the Guild implement a service quality system that would establish an industry-wide strategy capable of: Consistent service performance Improved service quality Controlled consumer advice processes Effective merchandising procedures Industry self regulation Training and performance initiatives Tangible business improvement Internationally recognised best practice.

A four phase process was proposed by the CR Group to develop and trial a pharmacy service quality system and included the design and build of the service, implementing a pilot, preparation for full implementation and full implementation. The proposed pharmacy service quality system was to be based on learnings gathered by the CR

10 Prosser G. Media Release. In: PGA File Series (330) CR Group and pharmacy 2000: future directions for community pharmacy



Group during their introduction of a similar service quality program for BP service stations. The Guild National Council considered the proposal at a meeting in April 1997 and agreed to the production of a template retail standards procedures manual which included a process of ongoing audit and quality evaluation. The template was funded from a Guild member levy that was raised to explore issues related to legislation and pharmacy ownership. A system that would assess against standards to ensure a consistent level of service to consumers was considered critical to provide justification to preserve ownership and the current drug scheduling. Approval for the conduct of phase one, design and build of a quality program was given by the Guild on 20 June 1997 following a resolution of the National Council in April 1997:

“That the Guild examine further the setting and implementation of mandatory standards of practice. That in the first instance, and prior to a further examination of the need for a pilot program to introduce a Pharmacy Gold Star Service Quality System, the Guild look at producing for its members a template retail standards procedure manual which includes a process of ongoing audit and quality evaluation. That this manual would be free to all Guild members, possibly to be paid for out of the levy.” 11

The ‘levy’ referred to was a levy on members proposed to raise funds for an ownership campaign (more precisely a campaign to preserve legislation restricting ownership of pharmacies to registered pharmacists). Views were expressed that the use of funds raised in this manner ought be able to be applied to development of standards as ‘standards were integral to the ownership debate’. The consensus was that the levy should be used to fund the standards of practice and the resulting motion which precedes the resolution quoted above, specifically links the concepts supporting the campaign to preserve ownership and the need to raise standards of practice and maintain the current drug scheduling regime as part of that campaign. This early linking of the program with the ‘ownership debate’ was to have important consequences. A steering group and then working party were formed to inform the work of the CR Group in the development, direction and positioning of the Quality Program and then the development of material for the launch of the program at the APP in March 1998. Representatives from the Guild, Australian Institute of Pharmacy Management (AIPM), the PSA, and the Australian Association of Consultant Pharmacy were on the committees. A wide range of national and international organisations were contacted to provide input to the development of the program and these included Australian pharmacy boards and schools of pharmacy.

3.2.4.2 Development of professional standards

Standards for pharmacy practice were also on the international agenda, and the International Pharmacy Federation (FIP) identified the need to develop standards for pharmacy practice in the early 1990s. A document titled ‘Good Pharmacy Practice in Community and Hospital Settings’ was endorsed by the FIP in 1993. The international guidelines recommended that national standards be established to represent the four main areas of good pharmacy practice. 11 Extract from Minutes of national Council. In: PGA File Series (383): The Quality care Program Committee



These were the: 1. Promotion of good health, avoidance of ill-health and achievement of health targets 2. Supply of medication and other items related to treatment either in the pharmacy or

in the patient’s home 3. Provision of advice and/or supply of medicine for self care of symptoms or ailments 4. Activities that influence prescribing and drug use. The recommendations on standards for pharmacy practice by the FIP informed the development of retail and professional standards in Australia. While this work was being undertaken by the CR Group (retail standards) and the PSA (professional standards), the Australian Association of Consultant Pharmacy was commissioned to investigate a framework for standard development. A report titled “Framework for Standards for Quality Pharmacy Services” was published in 1997(Ware G et al. 1997). This report examined models of practice from a number of sources including the Society of Hospital Pharmacists of Australia, the Australian Quality Council and the Quality Standards for Pharmacy in New Zealand. The recommended framework in this report suggested six key areas of practice: 1. Pharmacy organisation 2. Pharmacy clients 3. Staff 4. Information systems 5. Resource management 6. Clinical and pharmaceutical services. This framework was mindful of the FIP recommendations, but as pharmacy services are delivered from a retail or hospital platform, they also included elements that underpin the delivery of quality services. The PSA endorsed the framework in November 1997. The PSA Professional Practice Standards Development Project commenced in June 1998 with the Final Report on the project delivered in October 1999. This project developed standards in eleven areas, with preference to areas in which substantive guidelines already existed and were in use. In this context, professional standards were developed for the following professional pharmacy services: Health Promotion Dispensing Dose Administration Aids Patient Counselling Compounding Preparation of Cytotoxic Drug Products Comprehensive Medication Review Comprehensive Pharmaceutical Care Drug Information Service Liaison Pharmacy Pharmacy Services to Residential Care Facilities.



The PSA adopted a structure that, whilst giving emphasis to process and impact, included a self-assessment tool. This was considered important for the standards to drive continuous quality improvement (CQI), as opposed to reaching minimum targets (Quality Assurance). The PSA recommended that each standard comprise the following: Standard number and title Description or definition of the pharmaceutical service Standard statement Scope Criteria Indicators Footnotes Assessment scale Additional information References.

The Pharmacy Practice Handbook was written using the above criteria and was released by PSA to all members in February 1998. The Practice Handbook, contained(Pharmacy Practice Handbook 1998): PSA Policies PSA Position Statements Professional Guidelines.

Whilst designed as a resource for PSA members, it was the intent of the Council that the Professional Guidelines would form the underpinnings for more detailed standards that would be considered appropriate for the profession, whether members of PSA or not. Although the CR Group initially commenced work on developing professional standards, the PSA were invited to provide their material relevant to professional practice standards to the Guild. This information was then incorporated with the retail, human resource management and business management standards that the CR Group developed to form a single framework which could underpin a national community pharmacy accreditation process. The University of Sydney and University of South Australia conducted a research project into the handling of Pharmacy and Pharmacist Only medicines by pharmacies and this was funded from the Second Community Pharmacy Agreement. Standards for the handling of these medicines by pharmacy staff were developed as part of this project and informed the further development of professional standards. The standards re-issued in 2000 after the first review (1999) contained an expanded set of professional practice standards based on the eleven Professional Practice Standards developed by PSA, but modified by PSA to conform broadly to the format of the remainder of the QCP Standards. They do however retain the inclusion of the ‘Scope’ from the original Standards, whilst the ‘Action Required to Meet Standard’ section follows the Criteria set out in the PSA Standards. What is missing, compared with the full PSA Standard, are the Indicator subsets for each criterion, which assist in self-assessment.



3.2.4.3 Defining the standards

The standards comprise Pharmacy Standards and Team Standards, with the Pharmacy Standards incorporating overarching concepts and ‘whole of business’ issues, whilst the Team Standards apply these overarching concepts in an action sense – the ‘how we do things in this pharmacy’. Pharmacy Standards are: Professional Services Retail Skills Business Management Loss Prevention.

Team Standards are: Being Ready for Business Serving the Consumer Assisting the Pharmacist Dealing with Stock Loss Prevention.

QCPP staff suggested that feedback from pharmacists and staff regarding the Team Standards concept, and the use of the flipper chart which is designed to remain in the pharmacy service area for ready access by staff, indicated that this tool was arguably the best accepted and the most used by pharmacy staff. It also proved a useful focus for staff design, adoption and ownership of the standards at the pharmacy level. As defined in the Program CD ROM: Pharmacy Standards are “..the core document for pharmacy management.

These standards detail the key elements on which a pharmacy should focus to ensure consumer satisfaction, quality care and the ongoing success of the business” (Bridge 2001). The majority of these standards focus on managerial actions that will enable the pharmacy to provide quality consumer care, and to function successfully as a business. The remaining standards deal with aspects of professional practice for pharmacists and other dispensary personnel.

Team Standards “….outline the consumer standards that will need to be achieved by pharmacy staff. The team standards are aimed primarily at pharmacy assistants, but can apply to anyone working in the pharmacy. Each page in the Team Standards deals with a separate issue. The top part of each page describes why the issue is important and provides general suggestions for dealing with the issue in an effective manner. The bottom half of the page is blank. Use this to write down the specific ways in which the issue will be handled in your pharmacy. The Pharmacist and staff discuss each issue in turn and agree to a team standard for dealing with the issue whenever it arises in the pharmacy. This process continues until a procedure has been agreed and documented for every issue in the Team Standards” (Bridge 2001).

The Retail Skills Standards incorporate reference to: Access, physical appearance, services and equipment, providing service and

advice Layouts and displays, providing the products people want, making stock easy to

buy Loss prevention.



The Professional Services Standards incorporate reference to pharmacist practice and pharmacy design. Prior to the first major review, in 1999, the Professional Standards were a brief subset of the draft professional standards then under development by PSA. The Business Management Standards incorporate reference to: Building up business, marketing and promotional, building and leading the team, relationships with external parties and accreditation processes (Bridge 2001).

3.2.4.4 Pharmacy assessment processes

The June 1998 meeting of the Quality Care Pharmacy Program Committee considered the question of ‘the audit process’ and adopted at that meeting a series of principles which remain as the basis of the current guidelines.12 Training of assessors was progressed by the development of a Certificate IV training program by the Northpoint TAFE in Brisbane. This program was a ‘generic’ quality training course with modifications to contextualise it to pharmacy needs. The Committee also resolved that, in the interests of fairness and expediency, the Guild would not seek to recover the development costs of the training (estimated at $38,000) nor the full delivery costs of some $680 per head for attendees (proposed charge was $395). This was seen as essential to ensure that sufficient and appropriate assessors were available to meet the assessment needs of the Program as it went forward. The June meeting further considered matters related to the question of assessment, and in particular the need to address “the key strategic issue: Training of an adequate number of suitable Assessors to meet all program requirements in all parts of Australia”13. Of particular importance was the issue of audits in rural and remote areas and there was acceptance that, in the interests of equity, pharmacies in the Northern Territory and the far north west of West Australia. It was accepted that, in these areas, audit costs would probably need to subsidised by the program, and that this may also be the cases in remote areas of Queensland and Western Australia. The issue of frequency of assessment was resolved following a report from the Industrial Relations and Training Division on 25 September 1998. This report recommended three yearly external assessments, supplemented by an annual self-assessment, and provided comments on comparisons with other accreditation programs. This report also recommended that assessors not be part of any Guild framework, owing to legal difficulties, but that a ‘free market’ for assessors be established. The report also recommended an annual membership fee of $150 to defray program costs and noted the comparative ‘cheapness’ of the Guild’s charges as opposed to similar programs.14

12 Minutes 24 June 1998The Quality Care Pharmacy Program Committee’ PGA file series 383 ‘Quality Care Pharmacy Standards 13 Ibid. 14 Report of the IR & Training Division to Program Committee 25 September 1998. In: PGA file series (383) Quality Care Pharmacy Standards The Quality Care Pharmacy Program Committee



Whilst all assessors are required to be qualified at a Certificate IV level or higher, they need not be pharmacists. This policy has been recently reviewed and confirmed.

3.2.5 LAUNCH OF QCPP

3.2.5.1 Pilot of program

The pilot implementation program was conducted by the CR Group from December 1997 to February 1998 in trial sites in Melbourne and surrounds. Sixteen pharmacies from an initial selection of twenty-one participated in the pilot. Twelve of the participating pharmacies were members of a banner/brand group and the remaining four were independents. The pharmacies were selected on the basis of business size with three being small, seven medium and six large pharmacies. Pilot pharmacies were asked to assess the team standards and each pharmacy was allocated a sample of the standards to implement due to the time restrictions. Pharmacies in the pilot were required to: Read all materials and make written comments on issues that arose Work with their staff to develop pharmacy procedures related to their section of the

Team Standards Oversee the adoption in the pharmacy of the procedures developed for a period of

at least two weeks Attend a debriefing at the end of the pilot period.

Pilot pharmacies were supported by the CR Group during the process and expressed an overall positive response to the system. Pharmacists commented that the system assisted them in formalising procedures and manuals that had previously been filed in the ‘too hard’ basket. Pharmacies that believed they already had good procedures admitted that the systems helped in areas that they had overlooked and for accreditation to be meaningful, some form of monitoring would be required.

3.2.5.2 Implementation of QCPP (1998)

Guild members were notified of the ‘Pharmacy Standards’ by the National President in the National Newsletter on the 20th June 1997, in the context of the proposed review of pharmacist-owned pharmacies, and further referring to articles in the consumer magazine Choice. The articles “..made claims that pharmacies were not providing a quality health service to consumers, particularly in the sale of S3 products…”.15 Community pharmacy members were further informed by a telecast in November 1997. The telecast featured the National President of the Pharmacy Guild, Mr John Bronger, the Commonwealth Health Minister Dr Michael Wooldridge, the Shadow Health Minister Mr Michael Lee, and the President of the Australian Medical Association, Dr Michael Woollard. The tone of the telecast again reflected the ‘fight against deregulation’ theme.16

15 Bronger J. PGA National Newsletter. PGA file series (385) Quality Care Pharmacy Standards consultants - CR Group Stages 1,2 &3 16 PGA National Newsletter. In: PGA file series (385) Quality Care Pharmacy Standards consultants - CR Group Stages 1,2 &3



The program was launched at the Australian Pharmacy Professional Conference in March 1998. The initial documentation included a Standards Manual, a Reference Manual, a Flipper Chart which incorporated Team Standards and an Accreditation (later Implementation) Toolkit. The implementation toolkit contained comprehensive implementation assistance, as well as a number of certification documents and generic forms. The Introduction to the Program (CD ROM Version) states “The Implementation Toolkit contains materials that will need to be used during the process of gaining Pharmacy Accreditation. These materials are: Standards Implementation Guide – a comprehensive guide to the Program for the

pharmacist Staff Member Certification Workbook – each staff member is to be provided with a

copy, for use during the process of learning the team standards Certification Control Sheet – the pharmacist uses this to record the progress of all

staff members toward Certification Pre-Assessment Checklist – the pharmacist uses this to determine readiness for

the Pharmacy Accreditation assessment” (Bridge 2001). Also provided in the initial material was a Team Standards Implementation Video, produced by the Australian Institute of Pharmacy Management. The first release of QCPP Standards in 1998 incorporated twenty-nine Professional Service standards in the areas of: Pharmacy design and environment Managing the pharmacy Pharmacy services Maintaining the cold chain.

The professional standards used initially were derived from the professional standards then under development by PSA, but reformatted to ‘fit’ the format of other standards. One area that did pose difficulty concerned the ‘amalgamation’ of standards emanating from two sources, namely PSA and the CR Group. In the first release of the Standards, the Professional Standards followed the format of the entire Standards set, namely: Standard Action Required to Meet Standard Why It’s Important Support Available.

Following the March launch, by May 1998 commitments had been received by 2110 pharmacies associated with banner/brand groups and 215 independent pharmacies. The program was being managed from a newly created Division at the Guild within the Industrial Relations and Training Division. A Program Manager with a background in engineering and quality processes and one administration assistant were dedicated to the Program. Administration costs are estimated to have been in the order of $800,000 in 1998-99, and were $1.5 million in 2001-02.



Approximately $800,000 was provided by the Guild as seeding funds for the program and further management expenses were recovered through the sale of program materials and from an annual ‘membership’ fee of $165 including GST. The QCPP materials were sold to Guild members for $495, to non members for $695 and a bulk price of $205 per set was offered to the brand/banner groups as an inducement. This produced a positive response in term of the initial ‘sell in’ but did restrict the funds available to the program.

3.2.5.3 Program governance

Messer’s Sclavos, Hodgson, George and Nolte were appointed by the Guild National Council to form the Quality Care Committee of the Council. To these PGA members were added representatives from PSA, Australian Pharmacy Registering Authority (APRA), AIPM, AACP and the National Pharmaceutical Distributors Association (NPDA) and this group formed the Quality Care Pharmacy Program Committee, approved by the National Council of the PGA at its March meeting, and the first meeting of the ‘expanded’ committee was held on the 13th May 1998. This Committee had held seven meetings by November 1998 dealing with a wide range of design and implementation issues. The role of the Program Committee is to “provide professional and commercial advice to the Guild about the operation and effectiveness of the Program”17. Separate to the Program Committee, but central to the development of the professional standards was the Joint PSA/Guild Working Party. This working party was compact to assist in speedy resolution of issues, and comprised Kos Sclavos, the Chair of the PGA Project and Jay Hooper, the Chair of the PSA National Policy Committee and was formed in March 1998 18. The need for this committee arose from the requirement to negotiate with PSA over the use of the PSA Professional Standards under development, and to ensure that the Quality Care Program was all-embracing and that pharmacists were not referred to a number of different and potentially competing standards19. This joint working party was central to the design, implementation and roll-out of the program. In the words of Jay Hooper “if we had made that a bigger party, it wouldn’t have worked. ….it was matter of timing, place and opportunity that this worked” 20. The composition of this working group also reflected the acceptance by all parties that the final QCP standards were going to be much more than a set of retail standards (the original genesis), and that full co-operation between the PSA and the PGA was necessary to produce a program that had both industry-wide acceptance and a capacity to address all relevant issues. Following an informal meeting with industry groups on the 15th September 1998, an Advisory sub-committee was re-formed including representatives of the marketing/banner/brand groups and led to the pharmacy banners actively committing members to the program. The commitments are shown in Table 3.2.

17 Letter from S Greenwood to A Lamb 11 March 1998. PGA file series 383 ‘Quality Care Pharmacy Standards – The Quality Care Pharmacy Advisory Committee’ 18 Interview with Jay Hooper 15 July 2003 19 PGA file series 383 ‘Quality Care Pharmacy Standards – The Quality Care Pharmacy Advisory Committee’ Quality Care Pharmacy Program, Joint PSA Guild Working Party, Terms of Reference 20 Interview with Jay Hooper 15 July 2003



Table 3.2 Initial commitments by banner group

Banner Group Independents API 300 NSW 55 Sigma 500 VIC 59 Fauldings 450 QLD 66 Soul Pattinson 260 WA 8 Amcal 599 SA 18 Friendly Societies 100 TAS 8 ACT 1

By August 1998 the program became fully operational and 3000 copies of program material were printed and dispatched to those who had joined. A ‘1 300’ number was established and manned during office hours to provide and advice and support and received an average of 125 calls per week. A QCPP website was established on the Guild’s website and the hit rate was approximately 1800 per week. At this stage 427 independent pharmacies had joined. In order to assist pharmacies with the implementation process, the Australian Institute of Pharmacy Management was commissioned to conduct a series of workshops nationally to introduce the program, its concepts and the rationale for its introduction to community pharmacies. The workshop/seminar series ‘Raising the Standard’ was sponsored by Warner Lambert Pharmaceuticals and delivered at 45 sites with staff from some 600 pharmacies attending. The AIPM also developed the Implementation Toolkit on floppy disk and the Implementation Video. By November 1998 there was some concern on the uptake of the program and the Victorian Branch of the Guild reported on a phone survey of 40 pharmacies that were in the implementation process to gauge current progress. Some pharmacies had not yet unpacked the resources and others, although in favour of the concepts of standards, were overwhelmed by the apparent volume of work (the size and number of manuals) and the lack of time. In late 1999, 2700 pharmacies had purchased the QCPP materials which included the original commitment by the Banner groups plus 600-700 independent pharmacies. This left some 2300 pharmacies that had not yet decided to ‘buy into’, much less implement, the program.

3.2.6 ROLL OUT OF QCPP 2000-2005

3.2.6.1 Incentivising program uptake and implementation

The Guild and the PSA decided to incorporate the QCPP into the ‘deliverables’ of the proposed Third Community Pharmacy Agreement, and this Agreement subsequently became operative on 1 July 2000. The Australian Government recognised the value of QCPP in delivering higher quality service to the public and the Third Agreement provided an amount of $50 million to encourage pharmacies to enrol as members of the QCPP, to purchase all program materials and to become accredited as Quality Care pharmacies. At this point, the Australian Government Department of Health and Ageing became stakeholders in the QCPP. As a result of this initiative, on 1 October 2000 the ‘QCPP Financial Incentives’ initiative was launched, with the following incentives available:



$2500 Registration Incentive - for completion of the Application Form and purchase of all program materials (this incentive was designed to cover the cost of purchase of all materials and to cover some of the early implementation costs)

$7500 Accreditation Incentive - for accreditation as a Quality Care pharmacy (this incentive was designed to offset some or all of the costs of implementation, including the costs of external assessment) if accreditation occurs before 1 January 2004

$3000 Accreditation Incentive - for accreditation as a Quality Care pharmacy (this incentive is designed to offset some or all of the costs of implementation, including the costs of external assessment) if accreditation occurs on or after 1 January 2004

a $2500 Re-assessment Incentive– for a successful assessment where an accredited pharmacy (which has been paid the $7500) is sold in respect of all of its interests and is required to undergo another external assessment within 120 days of the date of change of ownership in order to maintain the accreditation (this incentive is designed to cover the costs of reviewing all of the Standards that were put in place by the former proprietor, and the costs of a further external assessment).

3.2.6.2 Administrative changes

With the commitment of incentive funding for the Third Agreement, the QCPP was managed by a separate Division at the Guild National Secretariat. Additional administration staff were employed to manage the incentive process and the Health Insurance Commission (HIC) made the incentive payments to pharmacies.

3.2.6.3 QCPP Division mission and objectives

A mission statement and team goal for the administration of the QCPP was framed and placed on the QCPP website and is as follows21:

“Mission Statement The Quality Care Pharmacy Program strives to provide all the support necessary to enable community pharmacies to achieve world’s best practice in the delivery of health care services and advice to the Australian public. The National Secretariat Support Team The Quality Care Pharmacy Program is administered from the Guild’s National Secretariat in Canberra. The team currently consists of the following personnel: the Divisional Director; the Administration Manager, the Communications and Promotions Manager, the Executive Assistant to the Divisional Director, the Senior Administration Officer; two Administration Officers; the Database Manager and seven Agreement Coordinators that are out-posted in each of the Guild’s Branch offices. The Team Goal The Quality Care Pharmacy Program Team is committed to serving the best interests of all community pharmacies with friendly service and helpful advice in implementing the Program and achieving accreditation. Team members can be contacted on 1300 363 340 to provide information and advice on all aspects of this important Guild initiative.” (Bridge G 1998)

21 www.qcpp.com



The program originated as a defence to threats facing community pharmacy (deregulation, ownership, scheduling of medicines) and incorporated professional standards with the retail standards in the evolution process from 1997-2000 and as such the purpose of the program differed for the various stakeholders. What started as a defence to threats evolved to become a potentially proactive program that considered the needs of consumers, government and pharmacies to deliver medicines and quality health services in a specialised retail environment. In the July 2003 version of the Standards Implementation Guide22, a description of the QCPP states that the program has been designed to make it easier to consistently meet the expectations of pharmacy’s customers and run businesses more effectively, and ultimately, more profitably. The program was also designed to meet emerging needs for quality assurance. Pharmacies were expected to achieve a uniformly higher standard of: Service for customers Professional care for patients Morale and teamwork among staff Business performance.

Benefits to individual pharmacies were proposed to include: Elimination of sub-standard service delivery and more consistent service levels Increased consumer satisfaction and retention Reduced consumer price-sensitivity A heightened sense of teamwork between management and staff Higher staff morale Focussing management and staff on the factors that make a difference to

consumers and the business Less dependency on individuals (management and staff) Ease of training/inducting new staff.

3.2.6.4 Program reviews

3.2.6.5 Internal program review

David Norrish of the CR Group performed the first ‘review’ of the quality aspects of the program in general, and the development of the draft materials in particular, on 2 March 1998 following a request from the Program Manager Tony McNess.23 (The program was not yet launched). This review covered the origins of source material used to that date and noted that the draft system material had been the subject of general oversight by more than 100 individuals including the pilot pharmacies, various pharmacy organisations and professional bodies and Pharmacy Guild Executives in each state. Subsequent reviews/investigations have been conducted by Optim Training and David Norrish (3 October 2001). The review by Optim training was based on a small sample of ten pharmacies and was qualitative. As an initial look at the program it reflects views

22 www.qcpp.com/implementation_tools.htm 23 Facsimile to Tony McNess 2 March 1998 In: PGA File Series (386) Quality Care Pharmacy Standards Consultants Stages 4 & 5



consistent with those encountered throughout this part of the evaluation but is not of sufficient depth to be authoritative. The Norrish review consists of two parts. An initial ‘review and discussion’ in October 2001 (David Norrish’s views as to the state of the program), followed by a commissioned study. This commissioned study interviewed 17 pharmacists individually, a further 13 pharmacists in group interviews, two Third Agreement Co-ordinators , an implementation consultant and an assessor. Members of the QCPP team in Canberra were also interviewed24,25. The findings of this report are presented in depth, reinforced by quotations from the various participants. The findings can be summarised to two main areas: Mechanical issues with the delivery and implementation of the material Conceptual issues relating to pharmacy’s overall perception of the need for the

program and the reasons for adopting and/or maintaining the program. QCPP also commissioned an enquiry by Elliott & Shanahan Research 26 regarding the reasons underpinning the slowing in accreditation rate that had become evident in the early part of 2002. The Elliott & Shanahan research covered: Intention to take up QCPP Awareness and understanding of QCPP-related issues Awareness of benefits of QCPP Barriers to completing process/can they be overcome Level/type of assistance needed What messages/strategy positions would be most likely to trigger a positive

response and motivate pharmacists to complete QCPP. The ‘stand-out’ finding that reinforces the findings in this evaluation is that 65% of the respondents cited ‘too busy’ as the reason for not commencing QCPP implementation. The various ‘drivers’ that either serve to promote uptake, or act as inhibitors of uptake, have been variously identified in the successive reviews (Table 3.3).

Table 3.3 Implementation drivers/inhibitors identified in reviews/reports/feedback

Optim Training

Nova Business Performance Services

Elliott & Shanahan

QCPP Reviews/ Feedback

Evaluation focus groups

Process Issues Time poor/ complexity Yes Yes Yes Yes Yes Unsure where to start Yes Yes Yes Push issues Avoidance of deregulation

Yes Yes Indicated some lack of awareness

Yes

Improve own business performance

Yes No Yes

Pull issues Consumer demand No Highlighted need

for consumer input

No No Somewhat

24 Pharmacist survey and recommendations for the future. A report by David Norrish of Nova Business Performance Services February 2002. 25 David Norrish’s views are significant as he was originally responsible for much of the drafting and implementation work associated with the introduction of the Program, and he has an extensive working knowledge of its history and intricacies. 26 Elliott & Shanahan Research. Survey among Pharmacists – Quality Care pharmacy program. October 2002.



3.2.6.6 Review of the standards

The QCPP underwent a review in 2000 and the most notable inclusion was the Pharmacy Manual of the Professional Practice Standards developed by the PSA and new standards for the sale of Pharmacy Medicines and Pharmacist Only Medicines developed by a consortium from the Universities of South Australia and Sydney. These standards had been endorsed by the major industry stakeholders and an early decision was taken that, when developed they were to be included in QCPP. The new standards were reformatted to make them consistent with the style of the QCPP standards. However, there was still a need for pharmacies to refer to the PSA publication as they contained important information and background notes to the standards, as well as a series of indicators which assist in determining whether the standards have been met. As a result of this need to refer to the PSA publication, they were included in the QCPP mandatory materials that all pharmacies required for accreditation. Another review of the program occurred in 2001 and three new professional standards were introduced. These were: Internet pharmacy medicine Distance dispensing Domiciliary Medication Management Review.

These new standards were considered mandatory if the service was provided by a particular pharmacy and all the actions required for the standard must be met for accreditation. An additional requirement for distance dispensing and internet pharmacy was that all accredited pharmacies who delivered the service needed to be independently assessed to maintain accreditation. As well as the Professional Practice Standards, two other new standards were introduced in the Pharmacy Manual. These were ‘Ongoing Compliance with Standards’ (a standard to assist with the maintenance of the QCPP within the pharmacy) and ‘Reporting to Pharmacy Owners (a standard which lays out the requirements for reporting to pharmacy owners, where the proprietor or partner does not work in the pharmacy for at least 20 hours per week). In addition, a new Team Standard ‘Medicare number collection and recording’ was introduced. The two reviews of the QCPP and changes to the program in the first two years were of concern to pharmacies, particularly the rate of change and development of the QCPP. The QCPP Committee recognised these concerns and decided on the following policies for further QCPP reviews: “There should be no further annual reviews of the QCPP Henceforth, the only changes to the Standards will be the introduction of new

Standards for new professional services, in accordance with out policy for the introduction of such Standards

If new Standards are introduced, they will be distributed to all members of the Program at the time they are finalised and the decision to include them in the QCPP is made



A full comprehensive review will take place following the completion of the Third Agreement R&D QCPP Evaluation Project, and after negotiations for a Fourth Community Pharmacy Agreement have been completed

This review will take place during the 2005-2006 financial year and will deal with all the issues arising out of the QCPP Evaluation Project, any requirements imposed by the Fourth Agreement, and any revisions needed to the Professional Practice and S2/S3 Standards as a result of review to be conducted of those Standards

It may be that after the 2005/06 review, the Program will be subjected to substantial surgery to take account of the evolution of the Program since its initial conceptual phase in 1997

In July 2006 all Program members will be provided free of charge with a completed set of updated materials, which would then last for the period of the Fourth Agreement, with a further comprehensive review to be conducted at the end of that Agreement.”

To assist pharmacies implementing the program, it was agreed that there would be a three month lead time from when a new standard was included in the program to when it would become assessable. This allows pharmacies in the process of implementation time to incorporate the standard. Pharmacies that are already accredited were expected to implement the new or amended Standards as part of their ongoing maintenance of the standards. Pharmacies that were accredited at the time of the introduction of new standards were not externally assessed against the standard until their next three-yearly assessment except under exceptional circumstances. The QCPP Committee determined that in the case of internet or distance dispensing, pharmacies offering these services needed external independent assessment against the standard by 31 December 2001. In relation to standard development, the QCPP Policy Committee ratified a policy for new standards on 26 November 2001. The policy for the Development of New Standards is as follows: 1. “The service must be available to all pharmacies 2. The standard will not be introduced until all aspects of the remuneration available to

perform the service has been finalised 3. The proponents of the new standards will need to pay to the QCP Division an

amount of $10,000 to cover the cost of the Division’s work in the development of the new standard and its accompanying material (Team Standard or Reference Manual support material). Printing of the Standard and its accompanying material and distribution to all QCPP members will also need to be met by the proponent

4. The development of any professional practice components of the new standards will involve the PSA under appropriate remuneration arrangements

5. The proponents of the new standard will need to cover the costs of developing an appropriate industry launch and information campaign, or pay to the Guild an amount to be negotiated (in the order of $50,000) to cover the costs of such.”

In July 2004, there were changes to two standards that involved pharmacy stock (STO-5) and control of access (MTP-5). The Guild view was that pharmacies must not compromise their professional role by selling or stocking harmful products such as alcohol and cigarettes. As such, the pharmacy stock standard became mandatory and



conditions to comply with this standard are listed 27. The control of access standard requires that the pharmacist in charge has access to the pharmacy 24 hours a day and seven days a week to meet the emergency needs of their consumers. The review policy of QCPP did not affect the implementation of any changes in the QCPP administration processes designed to introduce more flexibility into the system.

3.2.7 DATA MANAGEMENT

The administration of the program required data management systems to support operations and as such, the data management systems of the QCPP Division have undergone a similar evolutionary or continuous development process as the program itself. Details of the database development were obtained through an interview with Division staff. Prior to 2000, the data management system at the QCPP Division was largely aimed at a correspondence and payments received log to ensure that appropriate documentation was received, that timely notification/correspondence was despatched by the Division and that payments for the program had been received. Actual documentation was held in a hard copy filing system. The basic in-house database held standard membership details and recorded that correspondence that allowed accreditation progress to be tracked (including any remedial action required). This database was used until early 2001 through the development phase of a more detailed database that had greater functionality. With the announcement of the incentives package in late 2000, it became evident that the data management system would need to be expanded to facilitate the administration of the incentive scheme. A single data entry screen database was used to record the incentive scheme application data including PBS approval numbers and to track the mailing out of materials. In early 2001, as a need for greater functionality was identified, this database was enhanced to include accreditation status (including percentage scores of common and sampled items as provided by the assessor but not the various standards met) and self-assessment date/documentation tracking (not the results of self-assessment), and a letter production suite that automatically generated mailout lists for use in mail merging. Since 2001, the database has gradually been upgraded with additional functionality to support a range of administrative tasks: Invoicing and payments processing (including ‘banking setup’ to streamline

banking, account reconciliation and credit card processing) Systems to improve incentives claims processing by the Health Insurance

Commission (HIC). The system allows the Division to request the HIC to pay those pharmacies who have met the requirement of the program and to track whether those payments have been made by HIC. Anomalies related to the PBS approval number recorded in the database as belonging to a given pharmacy were noted as the main source of problems with delayed or refused incentive payments by the HIC. The system depends on the pharmacies to advise the QCPP Division of current approval numbers.

The database development to date has largely been related to the internal design of the database (data structure and relationships) to support the enhanced functionality with added security and better record editing controls (who last change a record and 27 http://www.qcpp.com/changes_to_standards_july2004.htm (accessed 7/7/04).



when). A validation rule set has been gradually created to minimise various types of human errors that have been identified as problems arise. The latest major change to the data management system in the QCPP Division occurred in May 2003 with the scanning and transfer of hard copy documents to an electronic document management system that is partially linked to the administrative database. Note that the contents of the documents (actual assessment scores, reported self-assessments) are not available for data manipulation and would require data entry should monitoring of assessment activities be undertaken as part of the function of the Division. Another issue is record retrieval - there are problems in finding assessor documentation for a given pharmacy because of limited record linking but there are plans to resolve this issue. Strategic planning for the data management system has been considered in only the broadest sense as the database developers are unsure of the nature of the QCP program in the future and so just what functionality will be required (e.g. will there still be a need to manage HIC payments?). The main aspects being considered for the future are a move to a more powerful database platform (e.g. SQL Server) and creation of an on-line real-time version of the database. An on-line version of the database has a range of potential benefits by resolving some problems and improving the responsiveness of the Division: It would allow more up-to-date pharmacy records by allowing pharmacies to record

change of ownership or change of PBS approval numbers on-line and accreditation-related data e.g. self-assessment reports

Third Agreement Coordinators could access more current data on which to plan support activities rather than the current systems of reporting that may be 2 weeks out of date

An assessor could follow the status of the pharmacies they are to assess and could also report the results of assessment directly into the system (with appropriate validation).

While not identified by Division staff, an on-line version of the database would allow more detailed data capture and so facilitate internal quality monitoring by the Division, (such as examining inter-assessor variability or performance of pharmacies reporting self-assessments) to guide future improvements in the QCP program. At the present time, the purpose of the data management system is to facilitate day-to-day operations of the Division in terms of document and payment tracking and processing. Other than tracking accreditation status, there is no routine procedure to monitor the quality of assessments (e.g. was the assessor’s arithmetic correct?) and to monitor the functioning of the QCP program as part of any program improvement process. The Division receives a lot of potential monitoring data from assessors and through self-assessment reporting that is filed as proof of assessment – the actual content of these documents is not monitored or reviewed. Such monitoring might include, for example, an examination of self-assessment report to see: Whether any pharmacy admits to not applying standards signed off on at

accreditation (section 1 question 1 in self-assessment reports) Whether all requested attachments for self-assessments have actually been

submitted and whether these documents indicate ongoing compliance with



standards (i.e. actually examine the content of the attachments – at present, these documents are merely linked and filed)

Which 8 standards were selected by pharmacies for continuous quality improvement (CQI)

What CQI credits are claimed as part of monitoring the effectiveness of this aspect of QCPP).

While it is recognised that data management systems in the QCPP Division have undergone continual development and improvement, the further development of the data management systems should be guided not only by administrative necessity but by the principles of quality assurance and CQI for the program itself.

3.3 FORMAT AND STRUCTURE OF QCPP The format and structure of QCPP has evolved from the pilot version in December 1997 to the version current at July 2004. A review of the QCPP and standards (originally planned for 2005 -06) is being conducted in parallel to this evaluation with an expected reporting date of late-2004. The program was originally conceived to set standards for the retail components of pharmacy, but as community pharmacy delivers medicines and health services in a retail environment, the professional standards were developed by the PSA and included in QCPP. The format of the standards in the QCPP evolved from national and international guidelines and the influencing factors are discussed in the development of Retail Standards and Professional Standards sections of this chapter.

3.3.1 CATEGORIES AND COMPOSITION OF STANDARDS

The information for this section is current for the period to the July 2004 update. The QCPP standards are categorised into pharmacy standards and team standards. The pharmacy standards incorporate overarching concepts and ‘whole of business’ issues and the team standards apply these overarching concepts in an action sense – the ‘how we do things in the pharmacy’. The following table (Table 3.4) provides more information on the pharmacy and team standards. The current list of standards and a summary of their content, together with the assessment compliance level is shown in the appendix, section7 p241. The pharmacy standards section gives the detail of what is required, and the team standards are very practical and assist the pharmacy to implement the standard and involves all staff in the process. Following, is a list of the standards according to the four categories of: 1. Professional Services 2. Retail Skills 3. Business Management 4. Loss Prevention.



Table 3.4 Comparison of two types of QCPP standards

Pharmacy Standards Team Standards

Overarching concepts and ‘whole of business’ issues.

Apply overarching concepts i.e. the ‘how we do things in this pharmacy’

‘..the core document for pharmacy management. These standards detail the key elements on which a pharmacy should focus to ensure consumer satisfaction, quality care and the ongoing success of the business’ (Bridge 2001) The majority of these standards focus on managerial actions that will enable the pharmacy to provide quality consumer care, and to function successfully as a business. The remaining standards deal with aspects of professional practice for pharmacists and other dispensary personnel.’

‘..outline the consumer standards that will need to be achieved by pharmacy staff. The team standards are aimed primarily at pharmacy assistants, but can apply to anyone working in the pharmacy. Each page in the team standards deals with a separate issue. The top part of each page describes why the issue is important and provides general suggestions for dealing with the issue in an effective manner. The bottom half of the page is blank. Use this to write down the specific ways in which the issue will be handled in your pharmacy. The pharmacist and staff discuss each issue in turn and agree to a Team Standard for dealing with the issue whenever it arises in the pharmacy. This process continues until a procedure has been agreed and documented for every issue in the Team Standards.’ (Bridge 2001).

Include: Professional services Retail skills Business management Loss prevention

Include: Being ready for business Serving the consumer Assisting the pharmacist Dealing with stock Loss prevention

3.3.2 PREPARATION OF PHARMACIES FOR ACCREDITATION

Pharmacies prepare for accreditation in a variety of ways depending on business size, number of staff, access to resources other than the program materials, and the time available. Some pharmacies have received external support to prepare for accreditation and others create an internal working team to plan, implement the standards and prepare documentation. The QCPP has prepared a number of resources to assist pharmacies implement the program and prepare for an accreditation assessment. A section of the QCPP website 28 lists the tools and provides information, checklists and templates. The types of tools available include the following and these can be accessed on the website “Documentation relevant to each stage of your QCPP accreditation”: Reference Manual – Summary of Tools Special Assessors Checklist for PPS 12 and PPS 13 (Distance Dispensing and

Internet Pharmacy) Pharmacy appearance scorecard

28 www.qcpp.com/implementation_tools.htm (viewed 19/7/04):



Implementation case studies Licensed assessors Visual aid – QCPP materials Assessment methodology Implementation toolkit Implementation rulings Implementation assistance by assessors Implementation process guide Implementation schedule Pharmacy assistant position descriptions.

The Standards Implementation Guide was designed to be used as the major reference during the process of implementing QCPP so that the program could be implemented without outside assistance. Self implementation is advised so that maximum benefit is derived by the pharmacy in meeting and then maintaining the standards. Some pharmacies may use external assistance, but when a licensed assessor is used to assist with implementation, they are not able to undertake the formal accreditation assessment. The guide presents information on the process of setting and implementing the team standards in the pharmacy and certifying staff members. This information is well set out and provides practical suggestions on how to get started and complete the process and then ensure that adequate records are kept. The section on implementing the pharmacy standards suggests that the pharmacy identify any gaps between the pharmacy standards and existing performance and close the gaps. A pharmacy has two methods of ascertaining it they are ready for the accreditation assessment and this can be done by completing the Pre-Assessment Checklist 29 and/or undergoing an optional Preliminary Assessment by an external assessor. The Pre-Assessment Checklist is part of the Implementation Toolkit and lists all the elements that can be assessed during an accreditation assessment. The Checklist refers pharmacies to a Pharmacy Standards Checklist, the team standards and the PSA’s Professional Practice Standards. Pharmacies are advised to achieve a 100% score before organising an accreditation assessment.

3.3.3 PROCESS OF ACCREDITATION AND RE-ACCREDITATION

When a pharmacy is confident that they are ready for an accreditation assessment they contact an assessor who is licensed with the Pharmacy Guild of Australia. A list of assessors is available on the QCPP website or can be obtained from phoning the helpline on 1300 363 340. Assessors charge market rate fees for their services and for travel and expenses incurred. The steps involved in the external assessment are detailed on page 13 of the Standards Implementation Guide and the assessment is conducted according to the Assessment Methodology for Licensed Assessors that is part of the Implementation Toolkit. There are six sections to the assessment and this includes: 1. Mandatory Program Materials 2. Mandatory Documentation 29 www.qcpp.com



3. Mandatory Standards 4. Common Standards 5. Sampled Standards 6. Additional Standards (both mandatory and non-mandatory). Mandatory program materials The mandatory program materials consist of: The Pharmacy Standards (hard copy) The Team Standards (the ‘flipper’) The Reference Manual (hard copy) The QCPP CD ROM The PSA Professional Practice and Pharmacy Medicine and Pharmacist Only

Medicine publications The AIPM Business Plan CD ROM The AIPM Team Standards Implementation video.

All of the program Materials listed above must be in the pharmacy to comply with accreditation requirements. Mandatory documentation The mandatory documentation that is essential for accreditation includes a document that lists the pharmacy’s procedure for each of the team standards, a compliance with the pharmacy standards (signed off by the proprietor or pharmacy manager) and a completed workbook for every staff member for whom the team standards apply. This might be sighted by the assessor. Mandatory Standards There are sixteen mandatory standards listed in the Pre-Assessment Checklist and there must be 100% compliance with each standard. The mandatory standards include pharmacy standards POP 1 to 7, PPS 1,2,4,5, COL 1 to 4 and STO 5. These standards relate to professional services, cold chain and storage of medicines. Further information is available in the PSA documents and the Pharmacy Standards Checklist. Common Standards Common standards are non-mandatory standards that are important enough to be assessed as part of every accreditation assessment. To be accredited, a pharmacy must comply with 80% of the common standards. The common standards consist of pharmacy standards (PDE 1 to 7, SER 1 to 9, APP 1, QCP 1, BUB 1, SEC 1 to 7, SAF 1 to 4) and team standards (ATP 1 to 10, SAF 1 to 4, EP 1-6) and all the standards are assessed. Sampled Standards Sampled standards are non-mandatory standards of relatively lesser importance, therefore only a 25% sample of these standards comprises an accreditation assessment. As for the common standards compliance with 80% of the sampled standards represents a ‘pass’. Pharmacies are not informed which of the sampled standards will be included in the accreditation assessment. The 25% selection is achieved by having four assessment templates, (A, B, C, D) which each contain the mandated and common standards and a random selection of the remaining standards.



In this way, all ‘remaining’ standards are assessed across the four templates. A pharmacy is not to be assessed twice sequentially using the same template. Additional Standards This section covers professional practice standards for services that only some pharmacies provide and refer to dose administration aids, cytotoxic drug products, medication reviews, distance dispensing, internet pharmacy, and medication assistance service (PPS 3,6,7,11,12,13,14,15). If a pharmacy provides any of these services then they will be assessed against the standard and 100% compliance is required to pass. Pharmacies may also elect to be assessed against professional practice standards 8,9,10,16 and 17 and these refer to comprehensive pharmaceutical care, drug information service, liaison pharmacy, methadone service and needle and syringe program. These standards require a 80% compliance to pass. Therefore, for a pharmacy to pass an accreditation assessment they must have all the mandatory program material and documentation and compliance with standards as shown in Table 3.5.

Table 3.5 Standard sections, number of standards and pass mark(s) (as % of section)

Sections No. of Standards Pass Mark Mandatory Standards (100% compliance) 16 16 Common Standards (80% compliance) 55 44 Sampled Standards - 25% sample (80% of the sample must comply)

27 22

Additional Standards - if service provided (100% compliance) - elective (included at request of pharmacist)

8 possible5 possible

There are two possible results from the Pharmacy Accreditation assessment: Accreditation is recommended by the Assessor, or The pharmacy is given a maximum of three months to take remedial action to

correct the deficiencies identified. If the pharmacy has deficiencies to be corrected, the assessor will provide the pharmacy with a list of deficiencies that need to be corrected on a return visit to the pharmacy within the three month period. It may be possible that the remedial action can be assessed via a telephone interview between the pharmacy and assessor. If the deficiencies are not rectified in the time given, then the pharmacy will be required to undergo another full accreditation assessment. The assessor will then inform the Guild of the outcome of the assessment and the QCP Division will review the recommendation. If accreditation is granted, the accreditation documents will be forwarded to the pharmacy. These include an Accreditation Certificate, a Quality Care window decal, a page of QCPP logo bromides, a copy of the Program Rules, and QCPP Accreditation Presentation and Local Area Marketing Kits. Accreditation is only transferable on the sale of all interests in the business when the new pharmacy management undergoes a further external assessment within 120 days



from the date of sale. Otherwise, the pharmacy’s accreditation is regarded as lapsed and the pharmacy must cease displaying or using the logo, or otherwise portraying itself as a Quality Care Pharmacy.

3.3.4 MAINTENANCE OF STANDARDS

To maintain accreditation with the program between 3 yearly external assessments, a pharmacy is required to conduct annual self-assessments. Self assessments are conducted by completing a pro-forma which includes a report on a number of continuous quality improvement initiatives. The QCP Division will provide the self-assessment documentation two months before the first and second anniversaries of the initial assessment. Standard QCP-1 is related to ongoing maintenance of the standards and is used in the self assessment after initial accreditation. The standards states that pharmacies must have a system for monitoring and maintaining compliance with the QCPP standards. Indicators for the standards include: A timetable for reviewing the operation of each standard Record of results for the review of each standard and whether any

corrective/preventative action was required Record of results of the corrective/preventative action taken, including identifying

responsibility, date and action completed and confirmation that defect/potential defect was satisfactorily dealt with.

The effectiveness of the self-assessment process may be monitored by random checks which involve brief reviews of pharmacy operations and documentation. Pharmacies are given notice of a random check. The QCPP has commissioned the University of Sydney to set up a Quality Care Pharmacy Program Support Centre (QCPPSC). The purpose of the centre is to conduct Standards Maintenance Assessment (SMA) visits to pharmacies to monitor compliance with the Program. Pharmacies are given 6 months notice by the Support Centre of an impending SMA visit. The Third Agreement Coordinators in each state organise the SMA visits and used trained staff on contract to act as a consumer and act out a ‘scenario’. Pharmacy Medicine and Pharmacist Only Medicines scenarios are used and usually involve a symptom based request or a product based request in either schedule. Each month new scenarios are developed by the Support Centre. The Third Agreement Coordinator analyses a tape of the visit and provides that pharmacy with immediate feedback and then sends the tape and assessment sheet to the Support Centre for validation and standardisation. The QCPP Director is provided with data each month on the performance of pharmacies against the scenarios. If a pharmacy’s performance is unsatisfactory, then the pharmacy is offered training. SMA visitors also assess other standards at the time of the visit but performance against these standards is not reported to the QCPP Director at the present time.

3.3.5 NUMBER OF PHARMACIES ACCREDITED OVER TIME

Figure 3.2 shows the cumulative accreditation rate to August 2004. The peaks in accreditation numbers seen in Figure 3.3 and in Figure 3.4 can be attributed to specific initiatives or offers relating to the program and the impact of the incentives on the accreditation rate is clear and significant.



Figure 3.2 Cumulative accreditation numbers by month – Nov 98 – August 04

0

50

100

150

200

250

Nov-98

Jan-9

9

Mar-99

May-99

Jul-9

9

Sep-99

Nov-99

Jan-0

0

Mar-00

May-00

Jul-0

0

Sep-00

Nov-00

Jan-0

1

Mar-01

May-01

Jul-0

1

Sep-01

Nov-01

Jan-0

2

Mar-02

May-02

Jul-0

2

Sep-02

Nov-02

Assessment Dates

No.

of A

ccre

dite

d Ph

arm

acie

s Banner Non-Banner

Figure 3.3 The number of pharmacies accredited each month – Nov 98 to Nov 02



Figure 3.4 The number of pharmacies accredited each month – Jan 02 to July 04

Figure 3.5 Number of pharmacies registered as at October 2004



Figure 3.6 Number of pharmacies accredited as at October 2004

The current Access™ database dates from October 2000, at which time the registrations and re-registrations (from those pharmacies that had originally purchased a set of program materials) were entered into the system. The registration incentives had the effect of driving the majority of pharmacies with an HIC approval number into the system by the end of January 2001 although the registration incentive did not finally close until 31 October 2001, in which month a further 118 pharmacies registered. Registrations have continued to be received subsequent of that date but these pharmacies, although eligible for the accreditation incentive ($7500) did not receive the registration incentive ($2500).

3.3.6 CONTINUOUS QUALITY IMPROVEMENT

3.3.6.1 CQI and the QCPP Division

One of the central tenets of any quality process is that of continuous quality improvement (CQI). The program has had two major revisions of the standards themselves and there has been a marked increase in the capacity of the program to implement systems and processes since July 2000 following the increase in registrations subsequent to this date and the consequent increase in resources. The following ‘Service Guarantee’ provides a further example of these internal processes.30 and sets time limits for the delivery of Quality Care Pharmacy Program services (Bridge 2002). According to divisional policy, pharmacists can expect these service delivery standards to be met or bettered in at least 95% of cases. The longest response time is in respect of payments from the Health Insurance Commission (HIC). This process is outside the control of the Division although it is included for the purposes of information to pharmacists. QCPP staff advise that the response time is due in part to the complexity of the authorisation process involving as it does the HIC and the Department of Health and Ageing and the Division.

30 QCPP 2001 CD ROM



Table 3.6 The QCPP Service Guarantee. QCPP CD ROM 2001

Indicators for each target activity Number of working days

Assessment (done by assessors) Return of phone calls to pharmacies 2 Date for conducting Assessment after date of booking 30 Dispatch of Assessment Report or provide an exception report to the National Secretariat

10

1300 Help-line and help desk Return of phone call 1 Response to e-mails 1 Notification of a solution or any work in progress 5 Document processing Dispatch of the Assessment Information documents after advice of a planned assessment date

10

Dispatch of documents for Accreditation and Re-Accreditation after assessment report received

10

Response to new owner listing requirements for continued accreditation 10 HIC payments Payment of $7,500 incentive for initial Accreditation after assessment report received

65

Payment of $2,500 incentive for Re-assessment after re-assessment report received

65

Payment of incentive for Re-accreditation after assessment report received TBA Up-dates of website 25

Further indicators of an adoption of CQI principles are found in the Standard Operating Procedures (SOP) Manual and forms control procedures. The forms control procedures and List of Controlled Documents are currently in place and the SOP manual is completed.

3.3.6.2 CQI and accredited pharmacies

The QCPP acknowledges the importance of Continuous Quality Improvement (CQI) and it is incorporated as part of the self-assessment process for a pharmacy after accreditation. The process and requirements for CQI are as follows: 1. As part of the self-assessment report, pharmacies are required to implement and

monitor improvements against any eight of the 113 Pharmacy Standards 2. Pharmacies must then submit a brief report, using the template provided as an

indication of what is required, outlining the CQI initiatives undertaken 3. Where a pharmacy has not yet selected the CQI measures at the time of its self

assessment and is not in a position to report, it is required to identify the Standards on which it will report as part of its next self assessment

4. The QCP Committee recognises that CQI can occur in a number of different contexts, all of which enable proprietors to achieve the philosophical objective of CQI. Accordingly, the QCP Committee believes that participation in nominated activities throughout the year should provide credit against the QCPP CQI reporting requirement

5. A total of eight credit points will provide a full exemption from the QCPP CQI reporting requirement, whereas four credit points claimed will require the completion of four of the eight CQI template reports.



A list of the approved activities to be undertaken involve the pharmacist as well as the pharmacy assistants and include: 1. Participation in a Third Community Pharmacy Agreement Research and

Development Grants Program project 2. Attainment of PSA Annual Gold Questionnaire 3. Participation in Guild and PSA CPE or AIPM CPE courses or completion of an

ACPP distance learning unit 4. Participation in a National Prescribing Service pharmacy self audit 5. Attendance at APP, PSA and AIPM conferences 6. Completion of a PSA Disease State Management Package 7. Participation in the Quality Care Pharmacy Program Support Centre SMA visit 8. Accreditation by the AACP to provide Medication Management Reviews and

provision of a DMMR service or provision 9. Provision of a Medication Assistance Service (MAS) 10. Completion of the PSA Workshop for the use of consumer medicine information

(CMI) for community pharmacists 11. Pharmacy Assistant Training (various forms listed) 12. Participation in Pharmacy Pre-registrants’ Training 13. Completion of the most recent Guild Digest Survey 14. Completion of a Quality Care Staff Training Course conducted by the Training

Department of the Victorian Branch of the Pharmacy Guild 15. Attendance at the Good Health and Beauty Show presented by the NSW Branch of

the Pharmacy Guild 16. Attendance at the Australian Pharmaceutical Industries (API) Offshore Conference

to South Africa in 2004 17. Participation in state Pharmacy Educator training as coordinated by the QCPP

Support Centre as part of the SMA visit.

3.3.7 QCPP PHARMACY OF THE YEAR

The QCPP Pharmacy of the Year (POTY) Award was initiated in 1999 with the first award being made in April 2000. Winners to date have been: 2000 Berwick Amcal Pharmacy Berwick Victoria 2001 The Range Pharmacy Toowoomba Queensland 2002 The Friendlies Pharmacy Subiaco Western Australia 2003 Maleny Amcal Chemist Maleny Queensland 2004 Warnbro Fair Pharmacy Western Australia

3.3.7.1 Background to the award

The Award, (which is supported by Pfizer Consumer Healthcare Australia) was conceived with the following objectives to: Promote the program primarily to community pharmacy but also, to a lesser extent,

to consumers ‘Reward’ quality in community pharmacy Provide ‘role models’ from which other pharmacies might learn.



3.3.7.2 Entry and selection processes

The number of pharmacies entering the POTY Award since its inception totals 356, with the number of entrants for the 2005 Award declining sharply from previous years (32 as against 80 in 2004, 93 in 2003 and 94 in 2002). The view of those associated with the Award is that this may represent the exhaustion of the pool of ‘natural entrants’ for the Award and it is envisaged that the Award will be restructured for the 2006 year. The selection panel consisted of a representative from each of: The Pharmaceutical Society The Pharmacy Guild of Australia (QCPP Committee/Division) The Australian Institute of Pharmacy Management Pfizer Consumer Healthcare.

For the Awards in 2000, 2001 and 2002, winners were chosen by the selection panel on a State basis following a desk audit of entries submitted, with the national winner chosen from amongst the state winners following an inspection tour by the panel. In 2003, a similar process involving desk audit was used but this was performed by a state-based committee made up of organisational representatives similar to those on the national selection panel. The national winner was again chosen following an inspection tour. In 2004 and 2005, selection was on the basis of response to a questionnaire dealing with the pharmacy’s view on the extent to which it was able to answer certain questions based on implementation of a range of standards and again these were subjected to desk audit with the national winner being chosen by inspection but, in these instances, based on an analysis of specific compliance against a range of standards. The selection process for POTY has, in many ways, mirrored the overall development of the program, with the intellectual underpinnings of the process becoming more transparent and standardised as the Award has progressed. .