The Pharmaceutical Journal Vol 258 p899-904
June 28, 1997 Special Feature

Pharmaceutical care: the minnesota model

The concept of pharmaceutical care has been redefined and tested in a major community pharmacy trial conducted by the University of Minnesota. The editor of The Pharmaceutical Journal went to the university, which is in Minneapolis, to find out about the trial and to visit pharmacies using the new approach. His report follows

The philosophy

Pharmaceutical care was defined by Douglas Hepler and Linda Strand as the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life (Am J Hosp Pharm 1990; 47:533-43).
Linda Strand, who is an associate professor in the College of Pharmacy at the University of Minnesota, now says that that definition was incomplete. The definition she now espouses - and it is the one that has been developed at the Peters Institute of Pharmaceutical Practice within the college - is that pharmaceutical care is "a practice in which the practitioner takes responsibility for a patient's drug related needs and holds him or herself accountable for meeting these needs".
Professor Strand places great emphasis on the word "practice". A pharmacist working to this new definition ascertains all the medicines that a patient is taking, from whatever source, assesses them for reasonableness and effectiveness in the light of the patient's condition, develops a care plan and follows up progress on a regular basis.
Linda Strand and Douglas Hepler, who is based in the University of Florida, now find themselves on divergent paths. While Strand and the Peters Institute have been developing the total therapy concept, Hepler has been working on therapeutic outcomes monitoring on a one-disease-at-a-time basis, beginning with such common conditions as asthma, diabetes, angina, hypertension and hyperlipidaemia (J Am Pharm Assoc 1997;37: 145-8).
Professor Strand described the basis of the institute's philosophy of pharmaceutical care in a long interview with me.
She emphasised that the pharmacist's real focus was the patient. Pharmacists had to assume responsibility for providing a service of real value and in a way that they could be paid for it. It was much more than simply providing a product.
Pharmaceutical care was a practice, just like any other health practitioner's practice. It had a philosophy, a patient care process and a management system. If there was a difference between pharmaceutical care and clinical pharmacy it was that pharmaceutical care had a management system and clinical pharmacy did not. Clinical pharmacy was on the periphery of a system that was essentially a dispensary and being managed as such. Pharmaceutical care was a practice in which practitioners took responsibility for defining a patients needs and held themselves accountable for that. This was very different to the 1990 definition. In that definition the only thing that people seemed to have caught on to was "outcomes". But outcomes meant nothing out of the context of a practice.

Why was pharmaceutical care needed?
The philosophy started with the assumption that a profession was only justified if it contributed to the solution of a unique set of problems. Drug-related morbidity and mortality fulfilled that description. They required expertise of a professional nature.
Drugs could make people sick as well as better. And there was also a need to optimise therapy. That was why a rational approach was needed through pharmaceutical care.
But pharmaceutical care did not mean that drug usage was lessened. On the contrary, in practice it had been found that about 20 per cent of patients needed additional drug therapy.
The responsibility of the pharmaceutical care practitioner was to ensure that there was an indication for every item of drug therapy and that any drug used was the most effective and the safest and that the patient was compliant.
The patient's needs were there, whether pharmacists recognised them or not. Most patients had problems with their drug therapy. Society had yet to create a professional to meet those needs.

Did money spent on pharmaceutical care lead to savings elsewhere?
Data showed that half of all patients entering a pharmacy had a drug therapy problem that needed to be addressed. If not dealt with, it could lead to unnecessary costs, from wasting money on ineffective therapy to hospitalisation. The unnecessary costs had been estimated at between $5,000 and $25,000 per patient. But drugs were by far the cheapest form of therapy - pennies compared with the costs of surgery, psychotherapy, etc. It had not been possible in the Minnesota project to gather data on avoidance of physician or hospital costs as a result of the practice of pharmaceutical care - nobody had the necessary data - but its absence did not mean that pharmaceutical care should not be progressed. Insurance companies and other health care providers should not want their patients to be taking unnecessary or ineffective drugs.

What progress had been made with pharmaceutical care and what could be done to take the concept further?
In seven years, according to Professor Strand, the advocates of pharmaceutical care had changed the profession's mission and direction. But really to achieve change, progress had to be made on a broad front. It was no use focusing on one issue at a time.
To change a profession, they had to change regulations, reimbursement, education, practice, patient expectations, relationships with physicians, the responsibilities of professional associations, the physical structure of pharmacies and the attitude of the pharmacist. This was very difficult.
There was no single key that would unlock the whole system. Pharmacy was fragmented. The way forward could be to teach students pharmaceutical care as a practice. This was what other professions did. Pharmacists would also have to provide the service first, then seek payment afterwards.
The Minnesota concept of pharmaceutical care worked because it set out to find problems and solve them. It would undoubtedly be more widely adopted, but the practitioner might not be a pharmacist.
The institute was developing a curriculum to teach pharmaceutical care, but it would not be restricted to pharmacists, although the institute was not interested in creating a new professional. For the foreseeable future, the people who underwent the course would practise in pharmacies.
There was great resistance to change in the profession. But pharmacy needed to convert from "dispensing" to "dispensing and patient care", where pharmaceutical care was the practice and dispensing was a component of the service. And pharmacists would have to build a practice one patient at a time, just as physicians and dentists built their practices. As things stood now, pharmacists did not know how many patients they had, just the number of prescriptions they dispensed.
The institute had not been brave enough to say that pharmaceutical care had to become the practice of pharmacy. However, pharmaceutical care did not eliminate dispensing or devalue it. It put dispensing in its position as a tool to deliver good drug therapy, not an end in itself.
Pharmacies would need to be restructured internally, otherwise the old ways would be perpetuated and the dispensing model would continue. The necessary changes were not great - they mainly concerned the area for patient interview - and pharmacies would not necessarily look much different from how they looked now.
To build a practice, pharmacists would have to start from the beginning. But the good news was that a practice model had now been defined and pharmacists who were sufficiently knowledgeable could carry it out. So building a practice was not as difficult as it sounded. It was mostly the mind-set of the pharmacist that was the barrier.
There was no assurance that pharmacists would do it. They would if they decided to act like a proper profession. But if they did not, the only certain way would be to require pharmaceutical care by regulation. Whichever way it was achieved, there would be a need for reimbursement systems paying for defined services.

What was the pharmaceutical care process?
Essentially, it was assessing a patient's needs, using resources to meet those needs and then following up to make sure that what had been done by the pharmacist was beneficial to the patient. The responsibilities were to ensure that all of a patient's drug therapy was appropriately indicated, effective, safe and able to be complied with by the patient - in that order. If a pharmacist counselled a patient to be compliant without establishing that a drug was truly indicated, he or she was part of the problem, not the solution.
The care process was connected fully to the philosophy. It comprised three steps: assessment of a patient's drug therapy needs; a personalised care plan that embraced those needs; and a follow up evaluation to make sure those needs had been met. The whole process needed to be fully recorded. Pharmacists could not interfere with people's lives without full documentation.
Those steps had not, in fact, been invented for the purposes of pharmaceutical care. They were part of every single health care practitioner's patient care process in every part of the world.
The resources needed to provide the service were a qualified person and a suitable physical environment (a desk, suitable reference ources, spaces for the patient to wait and to talk to the pharmacist and a patient care documentation system).
The next step was to build the practice and demonstrate the value of the service. There was as yet little real understanding of the process. This was partly the institute's fault, because it had not published much. It would be correcting that deficiency soon.

Would some pharmacists specialise in particular areas of therapy?
In medicine there were generalists and specialists, both essentially using the same process, starting with diagnosis and going through to treatment and follow-up. There could be specialist pharmaceutical care pharmacists addressing a restricted group of drug therapy problems in depth. When the generalist pharmaceutical care pharmacist felt he could not cope with a particular patient he could refer him on to the specialist. Once the problem had been assessed, the patient would be referred back to the generalist.
The institute had developed the practice of pharmaceutical care as a generalist practice in the community because that was where patients spent most of their time.

The project

Pharmaceutical care as a concept has undergone a three-year trial in community pharmacy in Minnesota. The project ran from 1992 to 1996. The primary research question was: "Can the philosophy of pharmaceutical care be practised in community pharmacy."
The short answer, according to Dr Robert Cipolle (director of the Peters Institute), is: "Yes." The long answer will be found in a book on pharmaceutical care written by institute staff and to be published later this year.
Dr Cipolle outlined the project and its findings to me.
Back in 1991, pharmaceutical care had just been a concept. With funding from a range of sources (see below), the institute had been able to set up the Minnesota Pharmaceutical Care Project to test it in practice. The project had been an enormous success and, as well as proving the pharmaceutical care concept, it had generated a lot of valuable data about patients' care needs over a long period of time. The data were unique.
When setting up the project, the institute had asked all the pharmacies (about 800) in the state to participate. Some 260 had expressed an initial interest and representatives of 110 had come to the university for an initial meeting. The institute had then gone out in teams of three to look at virtually every one of those. The objective had been to get a representative sample using the variables: "private", "chain", "small volume", "large volume", "metropolitan" and "rural". But, in the event, it had been found that none of those factors was material. The only variable that made any difference was the practitioner. That made sense if another profession like dentistry was considered. The practice of dentistry was when the dentist had her fingers in a mouth. The external variables made no difference.
They had ended up with 10 pharmacies that were "converted" for pharmaceutical care. All the pharmacists underwent a training programme on how to provide care and were shown how to use the computer and documentation system to ensure that they were collecting data in a consistent fashion.
The care process comprised assessment, care planning and evaluation.
For the purposes of assessment, the pharmacist ensured that all drug therapy was indicated, effective and safe and identified any problems. The pharmacist needed to have the skills to do this and then to go on to create a care plan to resolve any problems and prevent further ones. A key component was the follow-up, where the pharmacist recorded outcomes, evaluated progress and reassessed treatment. Follow-up could be by telephone interview or by asking the patient to call in or to send a card or letter. If the pharmacist was going to be responsible for the outcome of drug therapy he had to know what happened. If pharmacists did not follow up they did not care, it was that simple.
For pharmaceutical care to be effective, practitioners had to be disciplined. Students loved the approach because it taught them how to think. The sequence in the patient interview should always be in this order: Indication (what are you taking this medicine for?); effectiveness (is it working?); safety (are you having any unwanted effects?) and compliance (how are you taking the medicine?). The indication question would help establish if any medicine was being taken unnecessarily, the effectiveness question should be able to identify wrong treatments and wrong dosages, and the safety question should identify adverse drug reactions and excessive dosages. The compliance question would ascertain whether the patient was taking the medicine properly.
The average time for an assessment was about five minutes. A lot could be achieved in that time if the pharmacist was systematic.
Dr Cipolle said that patients usually knew why they were taking particular medicines (though they might not use the precise medical terminology). If they did not, that could be a major problem. How could a pharmacist counsel someone who did not know why they were taking a particular medicine. Because of the community setting, with people making frequent visits, pharmacists did not necessarily have to get all the information all at once. In the last resort, the pharmacist could ask the physician.
Once problems had been identified, solving them was not usually difficult. And once problems had been identified and resolved then the matter of compliance could be dealt with.
The whole process was recorded on computer software using standard terms as far as possible, to facilitate data analysis.
Initially, the idea had been to develop a pilot project, expand to a large number of sites and then develop a computer program to document patient care undertaken. But it had become evident very quickly that a computer program was needed at once. It simply had not been feasible to record the necessary data on paper. As a result, a program had been developed (by Health Outcomes Management Inc, a local company which had already produced programs for medical practitioners) in the first six months.
The program was designed to help pharmacists care for large numbers of people over long periods of time. It had a relational database and could be searched for any variable or combination of variables. The latest version had been internationalised to allow use in South Africa (by a health insurance company). A Windows version was due in the autumn.
The first screen shows a patient entry master window, which offers a number of options, including a screen for recording patient demographic details, and facilities for recording care plan details, interventions and evaluations. There are 150 standard treatment protocols for all principal disorders stored within the program. Dr Cipolle said that these had been drawn up from referenced sources by the institute. They were only for information. It was up to the pharmacist to decide what to do. The computer could calculate bills.
Terminology for defining outcomes had been devised. These ranged from "resolved" (outcomes achieved and therapy completed) through "stable" (outcomes achieved, continue therapy) to "expired" (patient died while undergoing therapy).
A reimbursement system had also been developed, using the system of reimbursing doctors nationally as the model. This took account of the resources required to take care of a particular patient's needs and related to the complexity of the case and the knowledge and skills needed. The pharmacy system was based on the number of conditions being treated, the number of active medications (prescription and OTC, wherever acquired) and the number of drug therapy problems. The system had worked well during the project.
Dr Cipolle said that the whole package was not complicated. It was basically "low tech".
Dr Cipolle gave me a snapshot of one year's data from the 10 pharmacies from November, 1994, to October, 1995. It covered 5,480 patients (compared with over 9,000 covered by the three-year project as a whole). Those 5,480 patients (59 per cent female, 41 per cent male) provided 12,376 encounters, averaging about 2.3 encounters per patient. (Simply collecting a repeat supply of medication was not classed as an encounter.) Not all the patients at the pharmacies were receiving pharmaceutical care. Those who had been were working adults and their families insured through Blue Cross/Blue Shield, who paid for the pharmaceutical care of the patients concerned during the project. The average bill for an encounter was $12 (about £7.50) and this had gone down as the care process progressed (which meant that pharmacists providing this type of service would have to recruit more patients to maintain income).
Minnesota was the second healthiest state in the union. Most people went to their dentists twice a year, so the number of pharmaceutical care encounters was not unreasonable. Half (47 per cent) of the encounters were with 30- to 60-year-olds.
The most frequent indications for drug therapy for patients receiving pharmaceutical care were (in this order): sinusitis; bronchitis; otitis media; hypertension; pain; streptococcal throat; gastric disease (gastritis, reflux, ulcer oesophagitis); osteoporosis (oestrogen replacement therapy); allergic rhinitis; skin infections; depression; arthritis.
The institute had not known this before the project started. These disorders were now the basis of the first-year pharmacy curriculum. (They were teaching pharmaceutical care in the first year now. It put much of the rest of the course into context.)
The favourites for disease management (asthma, diabetes, hyperlipidaemia) were not in the list. Those disorders, though important, accounted for only 7 per cent of the indications. That particular agenda was being driven by the pharmaceutical industry. Disease management was not a good approach for a profession.
It had also been shown that pharmacists saw the same things over and over again, as did general medical practitioners. The basic conditions covered half of what the pharmacist needed to know.
The most frequent indication for patients over 65 was similar to the list above but also included hyperlipidaemia, diabetes and angina.
The most frequent indications for the under 21s comprised dermatological and eye, ear, nose and throat disorders.
Pharmacists identified and addressed 4,228 drug therapy problems in the year. The most frequent was that patients needed additional medicines (23 per cent). Unnecessary drugs accounted for 7 per cent of problems and adverse drug reactions 21 per cent (899 problems). Wrong drugs accounted for 16 per cent. This was why compliance was considered last. Why hurt people by insisting they took wrong medicines?
On 610 occasions (15 per cent) the dose was too low. Most of the medicines covered were prescription drugs and the physician's permission would be sought to change a dose. This could be done by the patient or the pharmacist.
In overall terms, 43 per cent of patients were found to have drug therapy problems, though there was no guarantee that all problems had been discovered.
Most of the effort went where there was nothing wrong (3,000 patients) or one drug therapy problem (1,000). Pharmacists tended to focus on the difficult cases, but these were few and that was not where the effort was needed.
There was an average of 0.8 drug therapy problems per patient. But many had multiple problems. None of the existing pharmacy benefits packages was picking these problems up. The insurance companies should be willing to pay for pharmaceutical care. The problem was that those that might be willing to do so wanted exclusivity - they did not want their competitors to be able to provide the same service. (A group in Iowa was running a pharmaceutical care project with an insurance company in that state.)
So far as outcomes were concerned, pharmaceutical care seemed to be having a positive effect. Drug therapy problems were being identified and resolved. Care assessments at the beginning of the year showed 43 per cent of goals being met. Later assessments gave a figure of 60 per cent. This improvement was due to the pharmaceutical care offered by the pharmacists.
Asked if this level of success could be achieved on a mail order basis, Dr Cipolle pointed out that pharmaceutical care was a face-to-face business. There was a therapeutic relationship. Pharmacists had to be close enough to people to touch them to care for them. Telephone follow-up was feasible, however.
The Minnesota project had had a lot of support - from the College of Pharmacy, professional organisations in the state, the state board, the drug industry and managed care and insurance companies.
Dr Cipolle said that the data from the computer system could be used for performance assessment on an individual pharmacy or pharmacist basis.
The funders of the Minnesota project were: The Merck Co Inc, Glaxo Inc, Blue Cross/Blue Shield of Minnesota, Diversified Pharmaceutical Services, PCS Health Systems, Aetna Health Plans and Med Centers.

The practices

The company that has developed the computer software used in the Minnesota project (Health Outcomes Management Inc, of Minneapolis) has bought two pharmacies to develop the program in a practice setting and to try out marketing techniques.
I visited one of the them. The Edina pharmacy is located in a high class residential area in south Minneapolis. It is a small unit, but specialises in the supply of medicines and health related items. There are no toiletries or other items of general merchandise on sale.
The pharmacy was acquired about eight months ago and is being developed as a pharmaceutical care practice. In charge of the project is Mr Michael Frakes, a pharmacist and president of the subsidiary company of Health Outcomes that is developing the pharmacy system. Mr Frakes said that a computer system was needed to operate pharmaceutical care. Paper was too slow.
Mr Frakes said that in the United States, physicians often did not keep records of patients' medication and people often did not see the same physician twice in a row. For many, the pharmacist was the only professional they usually used. This was why the personalised pharmaceutical care plan created by the pharmacist and given to the patient was so valuable. It listed the medicines that the patient was taking, the reasons for taking them, the dosage regime, the prescribers, the intended outcomes and arrangements for follow-up. Brief general information was also given about the conditions being treated. Over-the-counter medicines were covered as well as prescription medicines. A summary chart was provided to be kept in a wallet or purse.
Mr Frakes noted that, in general, patients were taking twice as many drugs as recorded in a pharmacy patient medication record system.
As well as being of value to the patient, the patient could show their care plan to their physician or any other health professional treating them.
Twenty-five patients had signed up for pharmaceutical care at the pharmacy so far. One recent recruit had been found by the pharmacist to have dangerously high blood pressure and had decided to change doctors because her then physician had decided she did not need to be treated. On changing doctors, her treatment had started. The patients paid a fee for pharmaceutical care.
There were several major hurdles. One was getting patients interested in pharmaceutical care and another was getting that care paid for. Payment had been made to pharmacists during the Minnesota project, but nothing had been established since. Until a payment system was established it would only be practised in pockets on a local basis. The federal government had mandated patient counselling, so there were precedents for government action. A further hurdle was getting pharmacists to take up the system. The computer software had been available for some time, but there were still not many users. But Mr Frakes declared: "Pharmaceutical care is so right I can't believe it won't happen."
Good medicine was a good idea and health maintenance organisations should be promoting it, but unfortunately their main interest was in getting the patient's premium. No one seemed to care that many treatments with medicines were not working.
Insurers needed to be convinced that the service provided by pharmacists could be so much better. For $10 a month per patient, pharmacists practising pharmaceutical care could do everything that needed to be done. This was not a lot, considering the amount of money spent on ineffective drug treatment. A small amount of money was needed to solve a large problem. The most likely route forward would be in convincing health insurance companies that pharmaceutical care was worth paying for because it improved the quality of therapy. The professional organisations needed to be promoting the process. They should also be educating the public about the value of pharmaceutical care. All the data they needed would be in the forthcoming book about the Minnesota project.
When they had started out they had not known whether pharmacists could fulfil the new role. The Minnesota project showed that they could. The tools had been developed for pharmaceutical care. All that was needed now was the will and the means.

White Bear lake
The Bel-Aire pharmacy in White Bear Lake is owned by leading Minnesotan pharmacist Lowell Anderson, a former president of the American Pharmaceutical Association. The pharmacy did not take part in the Minnesota pharmaceutical care project, but one of the pharmacists who now practises there, Mr Tony Bose, did. Mr Bose took the course arranged by the College of Pharmacy and helped in the creation of the assessment tool (see p903) and is in the process of converting the pharmacy to pharmaceutical care.
Mr Bose told me that a lot of patients did not expect pharmaceutical care and, even if they accepted the need for it, were concerned about whether their health insurers would pay. Payment was, indeed, an issue. For the present, it was up to the individual pharmacist to make arrangements for a health maintenance organisation to pay for pharmaceutical care or ask the patient to pay. There had been some success with individual insurers, but many did not know how to deal with the matter. They were not accustomed to pharmacists operating in such a fashion.
So far, about 25 patients had been enrolled for pharmaceutical care. They did not necessarily have their prescriptions filled at the pharmacy. Forms had been developed to obtain medication information from other pharmacies used by the patient. Other pharmacists were willing to pass on such information. Patients were recruited using in-store leaflets and by placing information in prescription bags.
Asked whether any patients had experienced particular benefit so far, Mr Bose said that one had been on the wrong drug, and the physician had agreed to a change. Another non-complier would be a lot worse off were it not for pharmaceutical care. But it was early days.
Asked if he liked practising in this way, Mr Bose said: "I love it. It gives me the chance to feel I am doing something good for patients. I am really involved. Before, I only knew about patients superficially." It was an intellectual challenge. He really used his education. And by working in this fashion, continuing education programmes had much more meaning, because there were greater opportunities for putting the theory into practice. As he continued with pharmaceutical care, his knowledge base built up. It had, however, been reassuring to find out at the start that he had known more than he thought he had. Mr Bose emphasised that support personnel were essential. Without them, pharmaceutical care would fail. Pharmaceutical care pharmacists had to be freed from the routine of dispensing. But pharmacists could not excuse themselves from pharmaceutical care on the basis that they did not have enough time. When they had done some time and motion work in pharmacies operating in the traditional manner, it had been surprising how much time pharmacists spent on things that did not need their skill and training.
On the question of privacy, Mr Bose said that he did not believe it was right for the pharmacist to work with the patient in a totally closed-door environment. Means should be sought of assuring privacy without such physical separation from the rest of the premises.
He had no doubt in his mind: the pharmaceutical care model developed in Minnesota was the way to go. If pharmacists began helping patients in this way they would be making use of their skills and the whole process would snowball. It could develop in time to a situation where the doctor diagnosed and the pharmacists handled the treatment. As more and more pharmacist practised pharmaceutical care and suggested changes in treatment to benefit the patient, the more physicians would come to value their judgment. He was already beginning to notice such a response locally.