Clinical Outcomes Used in Clinical Pharmacy Intervention Studies in Secondary Care.

The objective was to investigate type, frequency and result of clinical outcomes used in studies to assess the effect of clinical pharmacy interventions in inpatient care. The literature search using Pubmed.gov was performed for the period up to 2013 using the search phrases: "Intervention(s)" and "pharmacist(s)" and "controlled" and "outcome(s)" or "effect(s)". Primary research studies in English of controlled, clinical pharmacy intervention studies, including outcome evaluation, were selected. Titles, abstracts and full-text papers were assessed individually by two reviewers, and inclusion was determined by consensus. In total, 37 publications were included in the review. The publications presented similar intervention elements but differed in study design. A large variety of outcome measures (135) had been used to evaluate the effect of the interventions; most frequently clinical measures/assessments by physician and health care service use. No apparent pattern was established among primary outcome measures with significant effect in favour of the intervention, but positive effect was most frequently related to studies that included power calculations and sufficient inclusion of patients (73% vs. 25%). This review emphasizes the importance of considering the relevance of outcomes selected to assess clinical pharmacy interventions and the importance of conducting a proper power calculation.

Investigating the Relative Significance of Drug-Related Problem Categories.

The aim of the review was to investigate whether an assessment of clinical significance can be related to specific drug-related problems (DRPs) and hence may assist in prioritizing individual categories of DRP categorization systems. The literature search using Google Scholar was performed for the period 1990 to 2013 and comprised primary research studies of clinical pharmacy interventions including DRP and clinical significance assessments. Two reviewers assessed the titles, abstracts, and full-text papers individually, and inclusion was determined by consensus. A total of 27 unique publications were included in the review. They had been conducted in 14 different countries and reported a large range of DRPs (71-5948). Five existing DRP categorisation systems were frequently used, and two methods employed to assess clinical significance were frequently reported. The present review could not establish a consistent relation between the DRP categories and the level of clinical significance. However, the categories "ADR" and possibly "Drug interaction" were often associated with an assessed high clinical significance, albeit they were infrequently identified in the studies. Hence, clinical significance assessments do not seem to be useful in prioritizing individual DRPs in the DRP categorization systems. Consequently, it may be necessary to reconsider our current approach for evaluating DRPs.

The challenges of outcome research.

Cognitive pharmacy trials seek to identify interventions that benefit patients. The potential benefits of an intervention are primarily evaluated by outcome measures. The question then is: What is the optimal outcome measure? Unfortunately, the question remains unsolved. Several factors must be taken into consideration when conducting outcome research-particularly within cognitive pharmacy trials. The interventions are often complex and non-specific, and seek to improve symptom control, optimise the use of medications and reduce medication-related risks. "Hard" endpoints, such as mortality and hospital admissions, may not be the optimal outcome measures, since cognitive pharmacy interventions are unlikely to result in changes in these measures. Instead, adverse drug events or "soft" endpoints, such as quality of life, drug-related problems and patient satisfaction may be appropriate choices of outcome measures. Finally, it is not only outcome measures that may pose a challenge when conducting outcome research; other essential components include study design, type of intervention, the patient population, etc.

[Development of patient-specific issues in relation to medicines is a challenge to all health-care professionals].

As a consequence of implementing clinical pharmacy at hospitals in Denmark, the need of defining some of the services delivered appeared: medication anamnesis, medication reconciliation, medication review and prescription review. Consensus was reached on the definitions with qualification by 20 colleagues from hospital pharmacies throughout the country as well as from external stakeholders. As an additional benefit, the definitions could cover the pharmacy services performed in primary care as well, which may help improve communication in the interface management of medication treatment.

Evaluation of a controlled, national collaboration study on a clinical pharmacy service of screening for risk medications.

BACKGROUND: Risk medications are frequently associated with adverse events and hospitalisations. OBJECTIVE: To evaluate a risk medication screening service for in-patients at Danish hospitals. SETTING: Danish hospitals. METHODS: The study was designed as a controlled, prospective intervention study. Inpatients were screened for the use of five risk medications; anticoagulants, digoxin, methotrexate, NSAIDs and opioids, and during the intervention period recommendations were made by clinical pharmacists according to a standardized intervention scheme. The recommendations were discussed with the physician face-to-face. MAIN OUTCOME MEASURE: Readmissions within 6 months after discharge. RESULTS: In total, 1,007 control and 775 intervention patients were included in the study. The study found that half of the patients (50 % during the control and 48 % during the intervention period) admitted to Danish hospitals were treated with at least one of the five selected risk medications, significantly more drug related problems (DRPs) were identified during the control period (1.7/patient during the control and 1.4/patient during the intervention period (p < 0.001)), and the acceptance rate of recommendations (62 %) was similar to medication management service studies in the literature (39-100 %). However, no impact on outcome measures was found. The majority (69 %) of the clinical pharmacists reported that they had increased their professional competences by participating in the study, and that a national clinical pharmacy study may be used in promoting and implementing a unique clinical pharmacy service throughout the country (67 %). CONCLUSION: The study showed that a national screening service for risk medications could help identify and address DRPs. Despite no impact on the selected outcome measures, it is likely that the screening service could be included in a medication management review with further focus on the individual patient to ensure positive outcomes, or that the screening service should be delivered to selected patients groups, who might have maximum benefit of the service.

Clinical pharmacist service in the acute ward.

BACKGROUND: The majority of hospitalised patients have drug-related problems. Clinical pharmacist services including medication history, medication reconciliation and medication review may reduce the number of drug-related problems. Acute and emergency hospital services have changed considerably during the past decade in Denmark, and the new fast-paced workflows pose new challenges for the provision of clinical pharmacist service. OBJECTIVE: To describe and evaluate a method for a clinical pharmacist service that is relevant and fit the workflow of the medical care in the acute ward. SETTING: Acute wards at three Danish hospitals. METHODS: The clinical pharmacist intervention comprised medication history, medication reconciliation, medication review, medical record entries and entry of prescription templates into the electronic medication module. Drug-related problems were categorised using The PCNE Classification V6.2. Inter-rater agreement analysis was used to validate the tool. Acceptance rates were measured as the physicians' approval of prescription templates and according to outcome in the PCNE classification. MAIN OUTCOME MEASURE: Acceptance rate of the clinical pharmacists' interventions through the described method and inter-rater agreement using the PCNE classification for drug-related problems. RESULTS: During 17 months, 188 patients were included in this study (average age 72 years and 55 % women). The clinical pharmacists found drug-related problems in 85 % of the patients. In the 1,724 prescriptions, 538 drug-related problems were identified. The overall acceptance rate by the physicians for the proposed interventions was 76 % (95 % CI 74-78 %). There was a substantial inter-rater agreement when using the PCNE classification system. CONCLUSION: The methods for a clinical pharmacist service in the acute ward in this study have been demonstrated to be relevant and timely. The method received a high acceptance rate, regardless of no need for oral communication, and a substantial inter-rater agreement when classifying the drug-related problems.