Three-Year Outcomes of Oral Antibiotics vs Intravenous and Oral Antibiotics for Uncomplicated Acute Appendicitis: A Secondary Analysis of the APPAC II Randomized Clinical Trial.

Importance: Current short-term evidence has shown that uncomplicated acute appendicitis can be treated successfully with oral antibiotics alone, but longer-term results are lacking. Objective: To assess the treatment effectiveness of oral antibiotic monotherapy compared with combined intravenous (IV) and oral antibiotics in computed tomography-confirmed uncomplicated acute appendicitis at a longer-term follow-up. Design, Setting, and Participants: This secondary analysis of a predefined year 3 follow-up of the Appendicitis Acuta II (APPAC II) noninferiority, multicenter randomized clinical trial compared oral moxifloxacin with combined IV ertapenem plus oral levofloxacin and metronidazole for the treatment of uncomplicated acute appendicitis. The trial was conducted at 9 university and central hospitals in Finland from April 2017 to November 2018, with the last follow-up in November 2022. Participants included patients aged 18 to 60 years, who were randomized to receive either oral antibiotics monotherapy (n = 301) or combined IV and oral antibiotics (n = 298). Interventions: Antibiotics monotherapy consisted of oral moxifloxacin, 400 mg/d, for 7 days. Combined IV and oral antibiotics consisted of IV ertapenem sodium, 1 g/d, for 2 days plus oral levofloxacin, 500 mg/d, and metronidazole, 500 mg 3 times/d, for 5 days. Main Outcomes and Measures: The primary end point was treatment success, defined as the resolution of acute appendicitis and discharge from hospital without the need for surgical intervention and no appendicitis recurrence at the year 3 follow-up evaluated using a noninferiority design. The secondary end points included late (after 1 year) appendicitis recurrence as well as treatment-related adverse events, quality of life, length of hospital stay, and length of sick leave, which were evaluated using a superiority design. Results: After exclusions, 599 patients (mean [SD] age, 36 [12] years; 336 males [56.1%]) were randomized; after withdrawal and loss to follow-up, 582 patients (99.8%) were available for the year 3 follow-up. The treatment success at year 3 was 63.4% (1-sided 95% CI, 58.8% to ∞) in the oral antibiotic monotherapy group and 65.2% (1-sided 95% CI, 60.5% to ∞) in the combined IV and oral antibiotics group. The difference in treatment success rate between the groups at year 3 was -1.8 percentage points (1-sided 95% CI, -8.3 percentage points to ∞; P = .14 for noninferiority), with the CI limit exceeding the noninferiority margin. There were no significant differences between groups in treatment-related adverse events, quality of life, length of hospital stay, or length of sick leave. Conclusions and Relevance: This secondary analysis of the APPAC II trial found a slightly higher appendectomy rate in patients who received oral antibiotic monotherapy; however, noninferiority of oral antibiotic monotherapy compared with combined IV and oral antibiotics could not be demonstrated. The results encourage future studies to assess oral antibiotic monotherapy as a viable treatment alternative for uncomplicated acute appendicitis. Trial Registration: ClinicalTrials.gov Identifier: NCT03236961.

Collaborative medication reviews in community pharmacies-Drug-related problems and the process of communicating them with physicians: A retrospective validation study.

Background and Aims: Cooperation between practicing community pharmacists (PPs) and primary care physicians has traditionally been limited, with scarce communication on therapeutic issues. The aim of this study was to assess how PPs communicate in writing with physicians regarding (1) the clinically relevant problems they have identified in patients' medications and (2) recommendations to solve the problems to identify development needs in the communication process. Methods: This retrospective validation study assessed medication reviews conducted by PPs in collaboration with home care nurses, practice nurses, and physicians for 46 older (≥65 years) home care clients in the Municipality of Lohja, Finland. The therapeutic and communicative appropriateness of clinically relevant drug-related problems (DRPs) identified by PPs and reported in writing to physicians was blindly evaluated by (1) an accredited pharmacist (AP) and (2) two physicians specialized in geriatric pharmacotherapy. Descriptive statistical analysis was conducted to compare the assessments. Results: The PPs (n = 13) identified 189 DRPs and made 4.1 recommendations per patient in 46 written reports to physicians. Of the PPs' written recommendations for medication changes, 46% (155/334) were the same as those by the AP. The two specialized physicians evaluated 69% and 67% of PPs' recommendations to be clinically relevant. The way the DRPs and recommendations to solve them were communicated was evaluated as appropriate in 38% and 38%, respectively, of the case reports written by the PPs. Conclusion: The PPs were able identify DRPs quite well, particularly inappropriate medication use, according to current care guidelines and formularies. It was found that improvement was needed in the communication of DRPs in written reports with physicians. Interprofessional learning by working in care teams would be suitable for strengthening patient care-oriented competencies.

Policy and vision for community pharmacies in Finland: a roadmap towards enhanced integration and reduced costs

Finland's community pharmacy system provides an example of a privately-owned regulated system being proactively developed by the profession and its stakeholders. Community pharmacists have a legal duty to promote safe and rational medicine use in outpatient care. The development of professionally oriented practice has been nationally coordinated since the 1990s with the support of a national steering group consisting of professional bodies, authorities, pharmacy schools and continuing education centers. The primary focus has been in patient counseling services and public health programs. The services have extended towards prospective medication risk management applying evidence-based tools, databases and digitalization. Research has been essential in informing progress by indicating high-risk patients, medications, practices and processes needing improvement. Despite the commitment of the profession and pharmacy owners, large-scale implementation of services has been challenging because of lack of remuneration, the pharmacy income still consisting primarily of sale of prescription and nonprescription medicines. Policy documents by the Ministry of Social Affairs and Health have supported the extension of the community pharmacists' role beyond traditional dispensing to promote rational pharmacotherapy. The current roadmap by the Ministry of Social Affairs and Health emphasizes ensuring adequate regional availability and accessibility of medicines, regardless of the future pharmacy system. It also emphasizes the importance of strong regulation on pharmacy business operations and sale of medicines to ensure medication safety. At the same time, the roadmap requires that the regulation must enable implementation of new patient-oriented services and procedures, and further promote digitalization in service provision. Competition and balance of funding should be enhanced, e.g., through price competition, but the risk of pharmaceutical market concentration should be managed. The regulation should also consider influence of the new social and health care system on drug delivery. Year 2021 will be crucial for making long-term political decisions on the future direction of tasks and finances of Finnish community pharmacies in this framework. Government-funded studies are underway to guide decision making. Ongoing Covid-19 crisis has demonstrated the readiness of Finnish community pharmacies to adapt fast to meet the changing societal needs

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Policy and vision for community pharmacies in Finland: A roadmap towards enhanced integration and reduced costs.

Finland's community pharmacy system provides an example of a privately-owned regulated system being proactively developed by the profession and its stakeholders. Community pharmacists have a legal duty to promote safe and rational medicine use in outpatient care. The development of professionally oriented practice has been nationally coordinated since the 1990s with the support of a national steering group consisting of professional bodies, authorities, pharmacy schools and continuing education centers. The primary focus has been in patient counseling services and public health programs. The services have extended towards prospective medication risk management applying evidence-based tools, databases and digitalization. Research has been essential in informing progress by indicating high-risk patients, medications, practices and processes needing improvement. Despite the commitment of the profession and pharmacy owners, large-scale implementation of services has been challenging because of lack of remuneration, the pharmacy income still consisting primarily of sale of prescription and nonprescription medicines. Policy documents by the Ministry of Social Affairs and Health have supported the extension of the community pharmacists' role beyond traditional dispensing to promote rational pharmacotherapy. The current roadmap by the Ministry of Social Affairs and Health emphasizes ensuring adequate regional availability and accessibility of medicines, regardless of the future pharmacy system. It also emphasizes the importance of strong regulation on pharmacy business operations and sale of medicines to ensure medication safety. At the same time, the roadmap requires that the regulation must enable implementation of new patient-oriented services and procedures, and further promote digitalization in service provision. Competition and balance of funding should be enhanced, e.g., through price competition, but the risk of pharmaceutical market concentration should be managed. The regulation should also consider influence of the new social and health care system on drug delivery. Year 2021 will be crucial for making long-term political decisions on the future direction of tasks and finances of Finnish community pharmacies in this framework. Government-funded studies are underway to guide decision making. Ongoing Covid-19 crisis has demonstrated the readiness of Finnish community pharmacies to adapt fast to meet the changing societal needs.

Effect of Oral Moxifloxacin vs Intravenous Ertapenem Plus Oral Levofloxacin for Treatment of Uncomplicated Acute Appendicitis: The APPAC II Randomized Clinical Trial.

Importance: Antibiotics are an effective and safe alternative to appendectomy for managing uncomplicated acute appendicitis, but the optimal antibiotic regimen is not known. Objective: To compare oral antibiotics with combined intravenous followed by oral antibiotics in the management of computed tomography-confirmed uncomplicated acute appendicitis. Design, Setting, and Participants: The Appendicitis Acuta (APPAC) II multicenter, open-label, noninferiority randomized clinical trial was conducted from April 2017 until November 2018 in 9 Finnish hospitals. A total of 599 patients aged 18 to 60 years with computed tomography-confirmed uncomplicated acute appendicitis were enrolled in the trial. The last date of follow-up was November 29, 2019. Interventions: Patients randomized to receive oral monotherapy (n = 295) received oral moxifloxacin (400 mg/d) for 7 days. Patients randomized to receive intravenous antibiotics followed by oral antibiotics (n = 288) received intravenous ertapenem (1 g/d) for 2 days followed by oral levofloxacin (500 mg/d) and metronidazole (500 mg 3 times/d) for 5 days. Main Outcomes and Measures: The primary end point was treatment success (≥65%) for both groups, defined as discharge from hospital without surgery and no recurrent appendicitis during 1-year follow-up, and to determine whether oral antibiotics alone were noninferior to intravenous and oral antibiotics, with a margin of 6% for difference. Results: Among 599 patients who were randomized (mean [SD] age, 36 [12] years; 263 [44%] women), 581 (99.7%) were available for the 1-year follow-up. The treatment success rate at 1 year was 70.2% (1-sided 95% CI, 65.8% to ∞) for patients treated with oral antibiotics and 73.8% (1-sided 95% CI, 69.5% to ∞) for patients treated with intravenous followed by oral antibiotics. The difference was -3.6% ([1-sided 95% CI, -9.7% to ∞]; P = .26 for noninferiority), with the confidence limit exceeding the noninferiority margin. Conclusion and Relevance: Among adults with uncomplicated acute appendicitis, treatment with 7 days of oral moxifloxacin compared with 2 days of intravenous ertapenem followed by 5 days of levofloxacin and metronidazole resulted in treatment success rates greater than 65% in both groups, but failed to demonstrate noninferiority for treatment success of oral antibiotics compared with intravenous followed by oral antibiotics. Trial Registration: ClinicalTrials.gov Identifier: NCT03236961; EudraCT Identifier: 2015-003633-10.

Enhanced coordination of care to reduce medication risks in older home care clients in primary care: a randomized controlled trial.

BACKGROUND: As populations are aging, a growing number of home care clients are frail and use multiple, complex medications. Combined with the lack of coordination of care this may pose uncontrolled polypharmacy and potential patient safety risks. The aim of this study was to assess the impact of a care coordination intervention on medication risks identified in drug regimens of older home care clients over a one-year period. METHODS: Two-arm, parallel, cluster randomized controlled trial with baseline and follow-up assessment at 12 months. The study was conducted in Primary Care in Lohja, Finland: all 5 home care units, the public healthcare center, and a private community pharmacy. PARTICIPANTS: All consented home care clients aged > 65 years, using at least one prescription medicine who were assessed at baseline and at 12 months. INTERVENTION: Practical nurses were trained to make the preliminary medication risk assessment during home visits and report findings to the coordinating pharmacist. The coordinating pharmacist prepared the cases for the triage meeting with the physician and home care nurse to decide on further actions. Each patient's physician made the final decisions on medication changes needed. Outcomes were measured as changes in medication risks: use of potentially inappropriate medications and psychotropics; anticholinergic and serotonergic load; drug-drug interactions. RESULTS: Participants (n = 129) characteristics: mean age 82.8 years, female 69.8%, mean number of prescription medicines in use 13.1. The intervention did not show an impact on the medication risks between the original intervention group and the control group in the intention to treat analysis, but the per protocol analysis indicated tendency for effectiveness, particularly in optimizing central nervous system medication use. Half (50.0%) of the participants with a potential need for medication changes, agreed on in the triage meeting, had none of the medication changes actually implemented. CONCLUSION: The care coordination intervention used in this study indicated tendency for effectiveness when implemented as planned. Even though the outcome of the intervention was not optimal, the value of this paper is in discussing the real world experiences and challenges of implementing new practices in home care. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02545257). Registered September 9 2015.

Coordinating resources for prospective medication risk management of older home care clients in primary care: procedure development and RCT study design for demonstrating its effectiveness.

BACKGROUND: The magnitude of safety risks related to medications of the older adults has been evidenced by numerous studies, but less is known of how to manage and prevent these risks in different health care settings. The aim of this study was to coordinate resources for prospective medication risk management of home care clients ≥ 65 years in primary care and to develop a study design for demonstrating effectiveness of the procedure. METHODS: Health care units involved in the study are from primary care in Lohja, Southern Finland: home care (191 consented clients), the public healthcare center, and a private community pharmacy. System based risk management theory and action research method was applied to construct the collaborative procedure utilizing each profession's existing resources in medication risk management of older home care clients. An inventory of clinical measures in usual clinical practice and systematic review of rigorous study designs was utilized in effectiveness study design. DISCUSSION: The new coordinated medication management model (CoMM) has the following 5 stages: 1) practical nurses are trained to identify clinically significant drug-related problems (DRPs) during home visits and report those to the clinical pharmacist. Clinical pharmacist prepares the cases for 2) an interprofessional triage meeting (50-70 cases/meeting of 2 h) where decisions are made on further action, e.g., more detailed medication reviews, 3) community pharmacists conduct necessary medication reviews and each patients' physician makes final decisions on medication changes needed. The final stages concern 4) implementation and 5) follow-up of medication changes. Randomized controlled trial (RCT) was developed to demonstrate the effectiveness of the procedure. The developed procedure is feasible for screening and reviewing medications of a high number of older home care clients to identify clients with severe DRPs and provide interventions to solve them utilizing existing primary care resources. TRIAL REGISTRATION: The study is registered in the Clinical Trials.gov ( NCT02545257 ). Registration date September 9 2015.

Comprehensive medication review: development of a collaborative procedure.

This commentary describes the development and evidence-base of the Comprehensive Medication Review (CMR) procedure for community and hospital settings in Finland. The development was coordinated by a national steering group. The group collaborated with 26 experienced pharmacists who developed and tested CMR procedures during a 1.5 year accreditation training for CMR. The development consisted of: (1) a literature review and inventory of medication review procedures in different countries; (2) the creation of potential procedures and related documentation; (3) integration of potential procedures into a national standard procedure; and (4) piloting the standard procedure in practice settings. The resulting comprehensive medication review procedure requires access to a patient's clinical information, an in-home patient interview and a case conference with the collaborating physician. This procedure covers the four main dimensions critical for safe and appropriate geriatric pharmacotherapy: aging and safety; co-morbidities; polypharmacy; and adherence. The CMR measures and documentation build on these dimensions.