Welcoming symposium attendees, Mr LOWELL ANDERSON (treasurer, APhA) said that pharmaceutical care was a relatively new term. Its current usage was less than a decade old. Pharmacists throughout the world had come to believe that the pharmacy profession had a greater role than that of the warehouse of drugs for other health professionals and that if the practitioners of the profession were to survive, the profession had to change. Conferences like the one in Miami were important. They allowed pharmacists to hear what colleagues around the world were doing and to maintain the momentum that had developed over the short life of the pharmaceutical care movement.
Success
As they worked to overcome each obstacle in the movement they were having reasonable success in the areas under the profession's control. These included the collection of data, the production of information, providing usable information to each patient, detecting and resolving problems, and improving drug therapy.
The external areas were much more difficult. These included acceptance by the purchasers and acceptance by other health providers. The main challenge here was that pharmacists had to prove that what they did was worthwhile. The challenge was especially demanding, because, as Douglas Hepler had said, evidence needed to challenge conventional wisdom needed to be of a higher standard than that justifying maintenance of the status quo.
Mr Anderson said that those at the symposium would hear reports from different countries, but at the core, regardless of culture, health system, and laws there would be pharmacists who had accepted responsibility for the appropriate use of medicines.
Divergence
In the chair for the conference was Dr JEFFREY POSTON (director, research and development, Canadian Pharmacists Association). Dr Poston said that a critical review of the papers on pharmaceutical care published in the eight years since Hepler and Strand's definitive paper (Am J Hosp Pharm 1990;47:533-42) had shown that only 57 out of 979 met criteria for pharmaceutical care as originally defined. This revealed a significant divergence in the use of the term.
Would the term "pharmaceutical care" suffer the same fate as clinical pharmacy, which blossomed in the hospital setting but failed to be translated into reality in community pharmacy practice?
The symposium was brought down to earth by Mr JOHN DUNLOP (manager, Comprehensive Pharmaceutical Care, Pharmaceutical Society of New Zealand). He said that pharmacists in the 1990s were really traders. Their primary activity focused on the supply of goods. Very few received the bulk of their remuneration from professional activities. That was also true in the hospital context, where relatively few pharmacists were employed to take responsibility for their pharmacotherapeutic decisions. The dispensing process had been reduced to a deskilled technical operation.
Pharmaceutical care was the pharmacists' opportunity to be professional by selling their intellectual property, directed at caring for and improving the quality of life of the population. There was no question that there was an immediate need for such intervention, given the appalling health statistics of drug related problems.
"The problem facing pharmaceutical societies around the world is to invoke the principles of change management and move those who are willing and capable from a trading mentality to that of a professional," Mr Dunlop declared. Failure to do so would see pharmacy written out of the health care team.
New Zealand had begun its foray into pharmaceutical care in 1994 when a contingent had visited the United States to gather information. In February, 1996, he had been appointed manager of the process in New Zealand. There was a staff of three.
They had elected early on to use the APhA training programme, which Australia had gained rights to use in the South Pacific. New Zealand had decided to align itself as closely as possible to Australia.
Early on they had made the discovery that it was impossible to charge for the pharmaceutical care process if it was added to the dispensing process. It had been decided to sell it as a consultative process needing a prearranged appointment. The Pharmaceutical Society of New Zealand had also promoted the concept of pharmaceutical care consultative practices independent of pharmacy. Until the process was established and proven there was little likelihood of Government funding. Third party payers remained interested spectators. So, at the moment, patients paid for the service if they used it.
The main obstacle for the implementation of pharmaceutical care was still the individual pharmacist's attitude to receiving payment for their intellectual property. To date, some 25 to 30 per cent of New Zealand's pharmacist had trained and were charging the patient.
The APhA training programme had been partly rewritten, while retaining the format and a large part of the content. They had moved away from some of the original concepts which, for example, suggested that pharmaceutical care could be undertaken at the time of dispensing. Staff co-operation was needed and a training programme had been developed for technicians and shop staff.
Peer support was an essential part of any change programme. The New Zealand society had set up "cell groups" of up to 10 pharmaceutical care pharmacists who met every four to six weeks. The pharmaceutical society's field educators - who were employed to visit each pharmacy at least once a year - organised the meetings. A network of clinical pharmacists had been established to peer review care plans.
The term pharmaceutical care had been applied in various ways round the world. Strand had coined the concept of comprehensive pharmaceutical care, and had defined exactly what she meant (see introduction). New Zealand had adopted the term and, as it was quite specific, had applied for trade mark registration. They had also developed a logo incorporating the term "comprehensive pharmaceutical care".
"Our reasons for doing this were to protect the defined process from misinterpretation by pharmacist practitioners, medical and other health professionals and the public," Mr Dunlop declared.
The contract with trained pharmacists allowed them to use the terms and the logo. Once pharmacists had been to CPC training they were offered provisional accreditation for 12 months. All care plans were sent in for clinical review. This took a week, but could be completed in two days if necessary. The pharmacist was obliged to pay $150 per month for a support programme. During the 12-month period they could apply for full accreditation.
Fully accredited pharmacists paid $300 per month, which covered a peer review process and a pharmacotherapeutic examination, undertaken every third year. Accredited pharmacists were required to submit 20 care plans each year and were required to undergo postgraduate education.
Standards of practice had been developed as a basis for the accreditation process.
Accredited pharmacists were provided with a supply of patient brochures entitled "How to get the best from your medicine". Also available was a "care card" for the pharmacist to give the patient at the end of the consultation. The card was filled in by the pharmacist and outlined the goals agreed to by the patient.
A national advertising campaign, using magazines, had been organised.
The New Zealand Society had been able to convince the Ministry of Health to include CPC in a standard governing the management of medicines in old people's homes and residential care facilities.
Five pharmaceutical companies had supported the introduction of CRC with one-off grants. The companies were briefed regularly on progress and showed great interest.
Calling for global action, Mr Dunlop said: "We just don't have enough momentum in each country to make a large enough impact with our respective governments. We need each other and the strength which can come from our combined international experience. We certainly need an internationally united political impact."
Asked about university curricula in relation to pharmaceutical care, Mr Dunlop said that, despite assertions to the contrary, he did not believe that students in his country were trained for pharmaceutical care. They still had the scientific rather than the human approach. Dr KAREN FARRIS (University of Alberta, Canada) said that in Alberta there were not enough practitioners to model pharmaceutical care behaviour. Dr FOPPE van MIL (The Netherlands) suggested that students be chosen for their interpersonal skills and caring attitudes, rather than high academic marks.
In a presentation on pharmaceutical care in Canada, Dr KAREN FARRIS (of the University of Alberta faculty of pharmacy and pharmaceutical sciences) said that, in 1993, the Canadian Pharmacists Association had adopted a mission statement that supported pharmacist provision of pharmaceutical care. The CPhA had also conducted a series of workshops looking at the realities of implementing the concept. These had dealt with the following subjects: turning theory into practice; developing PC in practice; getting paid; software; pharmacy technicians and research methods in evaluating PC. It had also worked with the Canadian Medical Association to produce a policy statement covering the role of the physician and the pharmacist in the management of drug therapy.
The working group on reimbursement methods had examined the Quebec model where pharmacists were reimbursed for not dispensing certain prescriptions as well as capitation models, fee for service and mixed models.
The Canadian Pharmacists Association was working on an electronic communication standard to allow pharmacists to charge for cognitive services and to record pharmaceutical care problems and the means chosen to resolve them.
One outcome of the workshops had been the Canadian pharmacy practice research group. This was a group of academics, practitioners and representatives from pharmacy organisations. It was hoped that there would be a group of pharmacy based researchers in each province able to conduct multi-site studies.
At the micro level, the CPhA was working on a practice innovation guide to provide guidelines for the initial steps for practice change.
Looking at developments on a provincial basis, Dr Farris said that in the early 1990s, many provincial pharmacy organisations had pharmaceutical care committees. The focus of many of those committees had changed over the years and had moved on to formulary management, managed care, and alternative reimbursement methods.
Within the universities, there were at least six initiatives under way implementing and evaluating pharmaceutical care. A project at Dalhousie university was using a practice change model within one community pharmacy; they were working with one community pharmacist to change what it was he was doing every day. This was being reported in the Canadian Pharmaceutical Journal. At the university of Toronto, there was a partnership between the university and community pharmacists to support practice change; the community pharmacists participated in a training programme and then university staff worked with them to change and maintain change at their practice sites. Manitoba, Alberta and British Columbia had ongoing or were initiating pharmaceutical care evaluative projects. The Manitoba project would have a comprehensive approach. British Columbia was using a therapeutic outcomes monitoring approach, currently with asthma, but moving on to hypertension and diabetes. Saskatchewan was supporting pilot projects pairing universities with pharmacists in the community.
In Canada, rather than taking one model, the CPhA and the provinces had facilitated what was going on within the provinces. The association was assisting with communication between the projects and increasingly that communication would be via the practice research group.
So there had been university, provincial and national initiatives as well as market place developments to facilitate the implementation of pharmaceutical care.
Dr Farris went on to describe the pharmaceutical care research and education project being conducted by the University of Alberta.
When they had started the project they had looked at the best that was being done at the time. They had visited the University of Iowa, the Minnesota project, and had recruited an academic with clinical experience from the University of Toronto.
The study objectives were:
In short, they were seeking to implement pharmaceutical care in community pharmacies and assess the processes, the things that pharmacists were actually doing as well as some of the patient outcomes.
In 1995, they had recruited 16 pharmacies from across Alberta. All were within a three hour drive of the university, which was based in Edmonton, to reduce travel. Eight had been randomised to a treatment group and eight to a control group.
Ten pharmacies remained. The loss in the project had been due to the workload involved in the practice enhancement programme as well as motivation. The drop out rate had been similar in both groups. At this time there were 395 patients in the study.
The focus was on the geriatric problem. The criteria were: 65 or older; on three or more concurrent medications; could complete telephone interviews; resident in Alberta for nine of the 12 study months; and providing informed consent.
The patients in the study received drug benefits from the provincial government. The researchers therefore had access to some quantitative claims data. The criterion of three or more medications had been chosen because it had been shown that there was an increased risk of non-compliance. The intervention was that pharmacists would provide comprehensive pharmaceutical care. This involved building a relationship between pharmacists and patients and meeting patients' drug-related needs. The model used a tool developed at the University of Toronto to identify drug-related problems. This was augmented by a "therapeutic thought process", a set of questions that pharmacists posed to themselves. These were:
The objective was to raise the level of drug related problems that pharmacists were able to identify. Pharmacists then prepared care plans and documented the care they provided, using the SOAP method developed by the University of Iowa ( SOAP = "subjective/objective assessment plan). The care plans covered such matters as clinical outcome, therapeutic endpoints, monitoring and follow up.
The main outcome variables were things typically seen in pharmaceutical care outcomes studies. They included the number of drug-related problems identified and resolved and the number of recommendations made and accepted. What researchers did expect to see was a change in the expectations of the patient. They would not expect to see a change in satisfaction scores, because everyone was "pretty satisfied" with their pharmacist now.
The practice enhancement programme required a number of "structural" changes in pharmacies to support the delivery of pharmaceutical care. They related to consultation areas, office areas, drug information retrieval and patient monitoring devices. There were also process changes related to patient history taking, medication care plans, communication forms and intervention/outcome documentation forms.
As part of the practice enhancement programme, pharmacists had had to complete five theoretical case studies, using computer mediated communications. In addition to theoretical cases, they had had to complete five practical cases.
All the pharmacists in the study were linked to the University of Alberta via a sophisticated e-mail package. They were also visited by the university's clinical co-ordinator/project manager (Dr Rosemin Kassam) every two to three weeks to help them stay on track and also to provide feedback.
The pharmacists were grouped, so that they could support each other.
The university was just completing a write up of the evaluation method being used to assess the practice enhancement programme. A "standard patient" had been trained and sent to the pharmacies concerned. The pharmacists had interviewed this "patient" and completed all the necessary documentation. This had been subjected to peer review. The results would be appearing in six months or so.
Last summer there had been quantitative interviews with the study pharmacists. Now that they understood the pharmaceutical care process they felt an increased responsibility to patients. But there was a constant struggle with their other responsibilities, such as families. It was a struggle for them to stay on task and to complete the intensive work ups they needed to do with their patients. However, every pharmacist expressed personal satisfaction with their impact on patient care.
There were challenges facing reformers. The resources needed for practice change were "way more than you think", Dr Farris told the audience. Practitioners currently were frustrated at the slow rate of change. And better evidence was needed of the cost-effectiveness of pharmacists' activities.
At the macro level, social marketing techniques were needed to change patients' expectations. And alternative reimbursement structures were needed to pay for pharmacists' time. The level of commitment required could not be sustained without different reimbursement structures. Better pharmacy software was needed, as also was funding for research.
Practice change was not the sole responsibility of community pharmacists. They needed support on a multi-stakeholder basis involving pharmacies, universities and professional associations. Practice-based research was essential.
When it was suggested during discussion that there might be problems with corporate bodies adopting pharmaceutical care - they might not want to change their businesses overnight - Dr Farris said that the pharmacies in her study were all independently owned.
On the question of securing clinical data, Dr Farris said that much could be learned from the patient. Mr JOHN DUNLOP (New Zealand) said that in New Zealand the patient owned the data and if a pharmacist wanted it all he had to do was ask the patient. Also, if pharmacists became members of the clinical team, they should have no difficulty in acquiring data.
Miss SHEENA MacGREGOR (Great Britain) described her work as a primary care pharmacist in a general medical practitioners' surgery in Dundee, Scotland, and, in particular, her role in the management of upper gastrointestinal disease.
She worked, she said, in a deprived area with a high rate of gastrointestinal disease. Her practice had five general medical practitioners and prided itself on being one of the most innovative in the UK. A wide range of clinics normally provided at a hospital were available in the surgery.
Funding for her post had initially been through a Scottish Office Home and Health Department research grant which had given her two years in which to demonstrate the potential for improvements to patient care and management of medicines through the integration of clinical pharmacists into the GP surgery based primary health care team. At the end of this period, the GP partners had felt that it was a worthwhile investment to use a proportion of the savings she had made from their drugs budget to continue to purchase her services and to develop her role further.
Miss MacGregor said that her role was largely a translocation of clinical pharmacy services into the general practice surgery with the pharmacist becoming fully integrated into the primary health care team in much the same way as a clinical pharmacist in hospital became part of the ward based team. The most obvious way that a pharmacist could assist a GP practice was through implementation and maintenance of a practice formulary, which then led on to audit of prescribing practice and development of disease management protocols. Once prospective prescribing was appropriate, repeat prescribing could be reviewed and pharmaceutical care issues for individual patients identified and managed. Time had become available to undertake more direct patient care activities and it was at this stage that the doctors had realised the skills that the pharmacist could offer and begun to delegate responsibility for the management of individual patients.
Management of any disease state involved a range of functions. Pharmacists were the most qualified to counsel and educate patients about their medicines. No one else was able to assess pharmaceutical needs and care issues for individual patients. Nurses could manage care of specified disease states from within agreed protocols. However, diseases seldom occurred in isolation and patients frequently took several medicines long term. Co-existing diseases could significantly affect treatment decisions and, other than the doctor, it was the clinical pharmacist who was best trained to evaluate risks and benefits. That, essentially, was the function of pharmaceutical care.
Miss MacGregor went on to discuss the management of the care of groups of patients. Initially, she said, the clinics that she had set up had been targeted at areas of unsatisfactory management. These had included anticoagulant monitoring, where patients had had to endure long waits and inconsistent management in hospital, and neurogenic pain, where the waiting time for a hospital appointment was 40 weeks. Experience with these clinics had established a management structure which could be adapted to other chronic diseases. It had demonstrated the benefits of pharmacist involvement and proved to be an acceptable approach to patients.
Miss MacGregor described her involvement with the treatment of patients with upper gastrointestinal disease. The practice had decided to devise a strategy to deal with the problem. Treatment would be diagnosis based and there would be a systematic approach to the management of new patients. Review of patients already prescribed medication would also be necessary. The GPs were overstretched and realised that the pharmacist had the necessary skills to promote rational and cost-effective prescribing, to educate patients on medicine compliance and lifestyle, to facilitate production of local guidelines and to manage review of patients.
Treatment strategies depending on diagnosis were agreed. The initial simple protocol had been revised several times to produce the current version, which formed the basis of the pharmacist led upper gastrointestinal management clinic. What had been established was a team approach with defined roles for different team members. The GP retained overall responsibility, but the pharmacist undertook organisation and day-to-day management.
There was an additional benefit in having a pharmacist rather than a nurse managing these patients and that was that the pharmacist could address additional pharmaceutical care issues at the same time. She gave an example of one patient seen at the clinic where treatment for hypertension was being compromised by a high sodium content antacid and an analgesic that could cause sodium and fluid retention.
Through the new procedures, a considerable overall saving in costs had been achieved.
The Dundee model illustrated how pharmacists could perform the prescribing function and might provide a framework for pharmacist prescribing in other chronic disease areas. The model could be adapted to any area of disease management when the decision to treat had been made by the doctor, with the pharmacist then managing future care of the patient within previously agreed guidelines. It was particularly appropriate in disease states where drug treatment required careful dosage titration and monitoring for adverse effects or had unpleasant side effects for which the patient needed counselling and management advice.
In a presentation on pharmaceutical care in Australia, Mr IRVINE NEWTON (president of the Victorian branch council of the Pharmaceutical Society of Australia) said that an address by Douglas Hepler at the Perth conference of the PSA had been like a spiritual awakening. For the first time, they had heard about a practice doing what pharmacy ought to do. Later, when Linda Strand had described at the PSA conference in Sydney in 1995 the process being implemented in Minnesota (see PJ, January 28, 1997, p899-904), there had been a realisation that this was something that pharmacy had to make happen. Those two people had sent Australia down the path of implementing pharmaceutical care.
A review of pharmaceutical care practice internationally had been undertaken by the Victorian branch. Visits had been made to Minnesota, Iowa and the American Pharmaceutical Association in Washington. Practice in Australia had also been reviewed. It had been found that a lot of patient counselling was taking place. This had been promoted by a concept known as "forward pharmacy". This required pharmacists to be accessible in a "forward" position and resulted in pharmacists sitting with clients at counselling desks at the front of the pharmacy away from the dispensing area. Pharmacists underwent specific training for this, usually in association with a wholesaler. It was not gold-plated CPC, but it was on the way. They had also found medication management, medication reviews and disease state management, but there had been no comprehensive pharmaceutical care.
The Victorian branch had decided to develop a practice standard for pharmaceutical care, with the eventual objective of making it a national project. It put together the Australian pharmaceutical care project. The driving force behind it was Alastair Lloyd (former director of the Victorian branch of the PSA), and if pharmaceutical care came to fruition in Australia it would be because of him.
They had bought the American Pharmaceutical Association's training programme on pharmaceutical care, which had been developed in the University of Iowa, and the first round of training had begun in July, 1996. The programme lasted five days. But only about 20 had participated.
Most pharmacists remained hesitant. This was disappointing, Mr Newton indicated. The practice of pharmacy in Australia lent itself to pharmaceutical care. There were no drug stores. There were no chains. Pharmacy computers were sophisticated in terms of medicines management and the taking of histories. There were fewer than 5,000 pharmacies, and pharmacists appeared ready to embrace the concept.
They had thought that they could change the world, but, two-and-a-half years later they had only changed "a bit of one suburb". Lots of people were planning lots of things, but not much progress had been made. One problem was that people were claiming lots of things to be pharmaceutical care, when they were not. People were constantly having to be reminded what pharmaceutical care was. Comprehensive pharmaceutical care was defined by the pharmacist and the patient agreeing to a consultation that fully utilised the pharmaceutical care process.
The hardest part was getting the pharmacist to change. There was no urgency. Pharmacists were doing well as they were. But in 1999, when the present five year agreement on provision of pharmaceutical services between the profession and the Government came to an end, conditions might change.
Most young pharmacists coming out of pharmacy school were ready for a pharmaceutical care type of approach - they wanted to talk to people - but it was the older pharmacists who were the problem.
Another problem was lack of support. More than a telephone help-line was required. Pharmaceutical care practitioners needed people calling on them offering help and encouragement.
Remuneration was also a key problem. The same question was being asked everywhere in the world: "Who is going to pay for this?"
Mr Newton said that the Pharmaceutical Society of Australia had now modified the APhA training course and was to launch a pharmaceutical care software programme to enable users to go through the care planning process.
The Pharmaceutical Society of Australia had to work harder to persuade pharmacists that they had to change. Pharmacists needed to make consumers more aware of what they were capable of.
He hoped that as part of the 1999 agreement with the government they would get differential dispensing fees for different services. Some people would be doing better, so they should be paid better. Clinical pharmacy on-site support should be developed. Role models should be identified.
Concluding, Mr Newton said that he saw no reason to believe that they were not on the right path in Australia. Some progress had been made. Pharmaceutical care was alive and well. "The challenge is to get pharmaceutical care on a broader scale, the consumer demanding it and convincing payers of the value of the service."
Dr FOPPE van MIL (department of social pharmacy and pharmacoepidemiology, University of Groningen, the Netherlands) said that countries in Europe were turning towards pharmaceutical care for a number of reasons. Almost everywhere the role and earnings of pharmacists were being questioned. With increasing drug budgets, governments were seeking ways to decrease the cost of health care. Patients were demanding more counselling and care. As on other continents, there was an increasing awareness in Europe that a chemical substance was only a drug when properly used. And the American health maintenance organisations and mail-order companies were looking for new markets and threatening pharmacy systems.
A number of research projects were being co-ordinated by the Pharmaceutical Care Network Europe, of which he was chairman. Therapeutic outcome monitoring studies, based on Hepler's work, were being carried out in nine European countries. These were being co-ordinated by Hanne Herborg from the College of Pharmacy Practice in Hillerod, Denmark.
Another co-ordinated study was dealing with the effects of pharmaceutical care in the over 65s using four or more drugs. It was based upon a framework developed by the University of Groningen in the Netherlands. James McElnay from Queens University in Belfast was the co-ordinator. There were seven participating countries.
In Spain a study into the effects of therapeutic outcome monitoring in coronary diseases had just been started. Since social pharmacy and pharmacy practice research in that country were rather weak, the research team co-operated with the department of preventive medicine of the medical school in Oviedo.
Denmark and the Netherlands were preparing a European study into the barriers to implementation of pharmaceutical care. Northern Ireland, Portugal and the Netherlands were piloting a study into pharmaceutical care in the eradication of Helicobacter pylori. The University of Manchester was developing a small European study into the effects of pharmaceutical care in OTC medication.
All practice studies safeguarded the elements of pharmaceutical care and there was co-operation with GPs in case the medication regimen had to be changed.
There were many other projects going on in Europe where the PCNE was not involved.
In January, 1999, the PCNE was organising a working conference in Hillerod for researchers to stimulate the construction of instruments for assessing the effects of pharmaceutical care.
Dr van Mil acknowledged that there were problems for pharmacists in participating in pharmaceutical care research projects like the one dealing with pharmaceutical care of the elderly. They had to invest their time. They had to fill in paperwork with patients; questionnaires assessing patients' knowledge about diseases and drugs seemed to cause annoyance to both patient and pharmacist. Studies could be too long. The care in the elderly study ran for two years. After 12 months, pharmacists had tidied up the drug list and answered most burning questions.
The drop out rate could be a problem with this type of patient study. It could be over 60 per cent. Nothing was more difficult than doing research in the practice situation.
As on other continents, Europe still had some way to go before every pharmacy delivered pharmaceutical care. The participants in PCNE, together with their partners, hoped to be able to stimulate all pharmacies to start.
The Pharmaceutical Care Network Europe had existed for five years but was still in its development phase.
Dr van Mil said that the PCNE was concerned with research into the professional aspects of providing pharmaceutical care, not reimbursement for providing such services. The conviction of the group was that the practice of pharmaceutical care was needed to maintain the professional standing of pharmacists.
Answering questions, Dr van Mil said that pharmaceutical care needed to be conducted in private. Patients felt uncomfortable if they could be overheard when discussing their health issues with a pharmacist.