Preventing drug-related morbidity--determining valid indicators.

OBJECTIVE: To describe the process that is being undertaken to validate a series of indicators for preventable drug-related morbidity - originally developed in the US - for application in the UK health care system. DESIGN: A two-round Delphi questionnaire survey after a preliminary validation of the indicators within the University of Manchester School of Pharmacy. SETTING: A primary care study set in the UK. STUDY PARTICIPANTS: A purposively selected sample of general practitioners with a specific responsibility for prescribing-related issues (n = 6) and pharmacists actively involved in medication review in primary care (n = 10). MAIN OUTCOME MEASURES: The establishment of consensus among the participants that an indicator reflected preventable drug-related morbidity in primary care. RESULTS: After preliminary validation, 37 of the original 57 US indicators were retained. The Delphi panel generated 16 additional new indicators in the first round. At the end of the second round, the pre-defined level of consensus was reached for 29 indicators (19 of the US generated indicators; 10 generated by the panel in the first round). CONCLUSIONS: The Delphi results highlighted differences in both the clinical perspective and, possibly, philosophical viewpoints of health professionals practising in the UK and US health care systems. Further work, located in both primary and secondary care, is now in progress to operationalize the indicators. This process will form a key part of the refining, and hence further validation, of the indicators. The future development of prospective medical-record-based indicators should facilitate a reduction in the human, clinical, and economic burden of drug-related morbidity.

Improving drug therapy for patients with asthma-part 2: Use of antiasthma medications.

OBJECTIVES: To describe the use of antiasthma drugs among the study patients and to evaluate whether therapeutic outcomes monitoring (TOM) is associated with improved quality of drug therapy. DESIGN: Prospective, controlled, multicenter study. Consumption of antiasthma medications was measured as the number of defined daily doses (DDDs) purchased. Data were collected from the pharmacies' computer systems for a period beginning 6 months before the start of the study (period 1) and during its first and second half-years (periods 2 and 3). Treatment changes for TOM patients were classified on the basis of drug regimens at periods 1 and 3. SETTING: Community pharmacies in Denmark (16 intervention, 15 control). PATIENTS: Five hundred patients with asthma aged 16 to 60 years who were being treated in primary health care; this study used data from 350 patients from this sample. INTERVENTION: TOM. MAIN OUTCOME MEASURES: Changes in the use of individual drugs and changes in therapeutic patterns--distribution of purchased drugs; proportion of corticosteroid users; frequency of drug regimens used; treatment changes for TOM patients. RESULTS: TOM patients' consumption of beta2-agonists decreased by 12% overall from period 1 through period 3, while control patients' consumption of these medications decreased by only 1%. TOM patients' use of inhaled corticosteroids increased by more than 50% compared with 9% among controls. In both groups, about one-half of all purchased DDDs were for inhaled beta2-agonists. The proportion of inhaled corticosteroids increased from 27% to 42% of total DDDs for the TOM group and remained constant for controls. Of patients using beta2-agonists, 68% also used inhaled steroids initially in both the TOM and control groups. The proportion of inhaled steroid users in the TOM group increased to 84%, and to 70% among controls. The most common regimen was inhaled short-acting beta2-agonists and corticosteroids in combination, and the second most common regimen was monotherapy with short-acting beta2-agonists. With time, the regimens changed more toward consensus guidelines among TOM patients. Changes in drug therapy totaled 451, averaging 2.4 changes per TOM patient. The largest number of changes (49%) involved inhaled corticosteroids. CONCLUSION: Changes in medication use among TOM patients were toward improved asthma treatment. Our results show that community pharmacists, physicians, and patients, working together, can improve prescribing, solve drug therapy problems, and improve outcomes for patients with moderate-to-severe asthma.

Improving drug therapy for patients with asthma--part 1: Patient outcomes.

OBJECTIVE: To evaluate the effects of a therapeutic outcomes monitoring (TOM) program on selected process and outcome measures. DESIGN: Prospective, controlled, multicenter study. SETTING: Community pharmacies throughout Denmark (16 intervention, 15 control). PATIENTS: Five hundred patients with asthma aged 16 to 60 years and treated in primary care. INTERVENTION: TOM is a community-based program for pharmaceutical care. Using a structured, seven-step, cyclical outcome improvement process, TOM pharmacists identify and resolve (or refer) problems with drug therapy that, if not addressed, might result in therapeutic failure or adverse effects. Equal emphasis is placed on the patient's perspective (e.g., coping, control, and empowerment) and the professional's perspective (e.g., adherence, patient knowledge, and therapeutic problems). TOM requires cooperation among pharmacists, patients, and physicians. MAIN OUTCOME MEASURES: Asthma symptom status, days of sickness, health-related and asthma-specific quality of life, use of health care services and resources, and satisfaction with health care and pharmacy. INTERMEDIATE OUTCOME AND PROCESS MEASURES: Peak expiratory flow rate (PEFR), knowledge of asthma and asthma medications, inhalation errors, and drug therapy problems in the TOM group. RESULTS: The mean individual differences for TOM and control patients were tested. Beneficial effects were found for the following outcome measures: asthma symptom status, days of sickness, and health-related and asthma-related quality of life. Satisfaction with health care and pharmacy varied throughout the course of the project, with no significant difference between groups at the final evaluation. Although not statistically significant, differences in use of services were considered to be clinically significant and encouraging. Beneficial effects were found for knowledge of asthma and medications, inhalation errors, drug use and drug therapy problems. No significant differences were found for PEFR. CONCLUSION: The project demonstrated that therapeutic outcomes monitoring by community pharmacists is an effective strategy for improving the quality of drug therapy for asthma patients in primary health care.

Regulating for outcomes as a systems response to the problem of drug-related morbidity.

OBJECTIVE: To describe the evidence that preventable adverse outcomes of drug therapy are prevalent in the United States and Europe, to describe the causes of this problem, to outline a systems response that would correct or improve the problem, to discuss pharmacy's contribution to that solution, and to propose a strategy for implementation. SUMMARY: The causes of the widespread problem of preventable drug-related morbidity (PDRM) that have been identified in the literature constitute system failure. Health professionals can understand an individual patient's care system if they organize their thinking about systems as efficiently as they organize their thinking about medical or pharmaceutical problems. Six essential system characteristics are proposed, based on the PDRM literature. Regulations should mandate regular patient and system performance assessments--specifically, that health professionals (1) identify, resolve, and document specific pharmacotherapy problems; (2) assess system performance and identify recurring root causes of problems; and (3) document assessments, problems found, actions taken, and follow-up. These regulations would, in essence, mandate individual quality improvement (QI) programs. QI and pharmaceutical care require similar processes of decisions and actions, one from a practice (multipatient) perspective and the other from a patient perspective. CONCLUSION: Health care accreditation agencies are moving toward regulation for outcomes. Pharmacy managers should embrace and regulatory boards should participate in this movement. Such regulations would clarify pharmacy's role in support of safe and effective pharmacotherapy and would constitute a commitment to pharmaceutical care as public service. A widely adopted system of measuring and improving the quality of medication use and outcomes could eventually lead to quality benchmarks in the community pharmacy setting, which would more firmly establish the value of the pharmacist in pharmacotherapy.

[Quality assurance of drug therapy for patients with asthma. Health economic analysis]. / Kvalitetssikring af astmapatienters laegemiddelbehandling. Sundhedsøkonomisk analyse.

The cost-effectiveness of a community pharmacy based programme for therapeutic outcomes monitoring of asthma patients' drug therapy is evaluated. Five hundred asthma patients, aged 16-60 and treated in primary care, with moderate to severe asthma, 31 community pharmacies and 139 general practitioners participated in the study. The total programme costs, costs of drugs, health care resource costs and indirect costs were evaluated together with the effects of the programme on: asthma symptoms status, days of sickness, quality of life, satisfaction with health care, peak-flow (PEF), inhalation technique and knowledge. The evaluation of the programme shows it to be cost-effective with cost-effectiveness ratios between 0.18 and 0.56. The pay off time for the programme is 23 months (range 9-64 months in the sensitivity analysis). It is concluded that the community pharmacist can contribute to identify and solve drug-related problems in a cost-effective way with positive impact on asthma patients health, clinical and psycho-social outcomes, even though the program is time consuming and intensive.

The Pharmacists' Implementation of Pharmaceutical Care (PIPC) model.

PURPOSE: Study purpose was to develop a theoretical framework that will explain pharmacists' behavior relative to the provision of pharmaceutical care. The model was developed from four attitude models by testing their predictive validity relative to pharmaceutical care implementation. Four hypotheses and one research question were investigated to identify determinants of behavioral intention and behavior. METHODS: 617 community pharmacists in the state of Florida, U.S.A., were surveyed twice using mail survey methodology to collect data. The first survey assessed community pharmacists' attitude, subjective norm, perceived behavioral control, past behavior recency, self-efficacies, instrumental beliefs and affect. The second survey assessed pharmacists' behavior relative to the implementation of pharmaceutical care. After establishing reliability and validity of measures, regression analysis was used to test hypotheses and research question investigated. RESULTS: The Pharmacists' Implementation of Pharmaceutical Care (PIPC) model developed postulates that (i) behavior is directly determined by past behavior recency, behavioral intention and perceived behavioral control; (ii) psychological appraisal processes-instrumental beliefs, self-efficacies, and affect toward means-influence behavior through past behavior recency; and (iii) behavioral intention is determined by attitude, social norm and perceived behavioral control. CONCLUSIONS: The PIPC model provides a formal scientifically validated theoretical framework which can be used to design successful intervention for pharmaceutical care implementation.

Therapeutic outcomes monitoring: application of pharmaceutical care guidelines to community pharmacy.

OBJECTIVE: To design a pharmaceutical care model, and develop and field test a set of community pharmacy guidelines and practice support materials--Therapeutic Outcomes Monitoring (TOM) modules. DESIGN: Concept interviews with pharmacists, physicians, and patients; development and field testing of practice guidelines. SETTING: Community pharmacies. PARTICIPANTS: Five independent, five chain, and two clinic site pharmacies. INTERVENTIONS: A prototype TOM module for asthma was developed through a seven-step process. Concept interviews were held with pharmacists, physicians, and patients to determine the desirability and feasibility of the TOM concept, prototype, and materials. Two field tests were completed and modifications made. Results were gathered through further concept interviews at the completion of the second field tests. MAIN OUTCOME MEASURES: Participants' opinions and experiences. RESULTS: Pharmacists, physicians, and patients expressed favorable attitudes about community pharmacists' participation in this pharmaceutical care model. Of the 12 participating pharmacists, 7 successfully implemented TOM in their practice sites and participated in the project throughout the testing; 49 patients were recruited into the study; and 22 patients remained in the program at the end of the second field test. In providing TOM services to these patients, the two most problematic areas for the pharmacists were in documenting care and reporting to physicians. A final phase of the TOM project has not been conducted in the United States because of insufficient numbers of patients for evaluating patient outcomes. CONCLUSION: The TOM project was successful from a technical but not a marketing perspective. Useful practice guidelines can be written and taught to pharmacists. Enrollment of patients was difficult, and the concept is not likely to spread spontaneously within the existing market for pharmaceutical services.

Pharmaceutical care.

Drug-treatment failures can be prevented by applying a Pharmaceutical Care system. Therapeutic outcome monitoring is such a system, which can be applied to the (drug) treatment of several diseases like asthma, diabetes and cardiovascular diseases. Pharmaceutical Care is an outcome oriented, cooperative, systematic approach to providing drug therapy directed at the improvement of all dimensions of health related quality of life.

Pharmaceutical care and specialty practice.

The practice of pharmaceutical care is a possible goal for all pharmacists' professional maturation. Six issues exist in which pharmaceutical care may represent a radical departure from some contemporary clinical practices. Because no profession is capable of providing pharmaceutical care singlehandedly at an acceptable level of quality, it is necessary to construct systems that organize the necessary variety of professionals and patients for managing drug therapy. In such a system, pharmacists can organize specialty practice around a strong general practice of pharmacy that is able to coordinate drug therapy and manage for outcomes, organize around the practice of medicine as if pharmacy were a medical specialty, or merge into the organization of a hospital or other healthcare organization.